Quality & Regulatory
Quality is part of our culture at FHC. Our Quality System is designed to support our mission to collaborate with our customers to develop and market innovative neurological research, surgical, and therapeutic equipment crafted to be the world’s finest. We have established and maintain a continually improving quality system based on ISO 13485, the Canadian Medical Devices Regulation (CMDR), the Medical Device Directive (MDD) and EU MDR in Europe, and the FDA Quality System Regulations. Our quality system documents all the processes and procedures we follow to design, develop, manufacture and ship quality products to satisfy our customers’ needs.
If you need to submit a Product Information Report, please download and complete the form and then fax or submit it to FHC Customer & Technical Support using the form below.
Fax Number: 207-666-8292
California’s Proposition 65, also called the Safe Drinking Water and Toxic Enforcement Act, was enacted in 1986. It is intended to help Californians make informed decisions about protecting themselves from chemicals known to cause cancer, birth defects, or other reproductive harm.
Ethelene Oxide is on the list of chemicals in Prop. 65.
The products included in this list are sterilized using EO and have residual levels of EO that are higher than what is allowed per PROP 65, therefore the following warning is required:
⚠ WARNING: This product can expose you to chemicals including Ethylene Oxide, which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information, go to www.P65Warnings.ca.gov.
| Part ID | Description | Sterile |
| C0230 | Guideline 5 3m uE Lead Cable | YES |
| C0231 | Guideline 5 1.5m uE Lead Cable | YES |
| C0232 | Guideline 5 1.5m Special-use Lead Cable |
YES |
| 22375Z | Sterile DZap Tungsten Short Profile | YES |
| 25375Z | mT Array Frame Platinum 5X Sterile | YES |
| 22670 | Box of 5 array electrodes | YES |
| 22670R | Array Electrode/Sterile 5pk | YES |
| 22675L | Array DZAP Leadpoint/Sterile | YES |
| 22675Z | Array DZAP/Sterile 5pk | YES |
| 34385Z | mT Frame Single Tungsten 5X Sterile | YES |
| 34680 | Box of 5 single electrodes | YES |
| 34680R | Single Electrode Sterile/5pk | YES |
| 34685L | Single DZap Leadpoint/ Sterile 5pk | YES |
| 34685Z | Single DZap / Sterile 5pk | YES |
| 35385Z | mT Single Frame Platinum 5X Sterile | YES |
| 44375Z | mT Platform Electrodes 5x Sterile | YES |
| 44970R | Platform Array Sterile/5pk | YES |
| 44975L | Platform Array Dzap Leadpoint | YES |
| 44975Z | Platform Array Dzap Sterile | YES |
| 45375Z | mT Platform Platinum 5X Sterile | YES |
| 5000R | Nexframe / Array Sterile / 5pk | YES |
| 5005L | Nexframe / DZap Leadpoint / Array Sterile/ 5pk | YES |
| 5005Z | Nexframe / DZap Array Sterile/ 5pk | YES |
| 5700R | Nexframe / Array Sterile / 5pk | YES |
| 5705L | Nexframe / DZap Leadpoint STar Drive Sterile/ 5pk | YES |
| 5705Z | Nexframe / DZap/ STar Drive Sterile/ 5pk | YES |
| 66-AC-DC | LeadLoc Depth Stop, Sterile | YES |
| 66-EL-EC | mTargeting Electrode Cable | YES |
| 66-EL-EC-01 | mT Electrode Cable w/ Alligator Clips | YES |
| 66-EL-LP | Patient Lead for LP+ | YES |
| 66-IT-IT1P | 5x Sterile Single IT Set | YES |
| 66-IT-01P | 5x Sterile Single IT Set | YES |
| 66-IT-03P | 5x Sterile Single IT Set | YES |
| 66-IT-05P | 5x Sterile Single IT Set | YES |
| 66-IT-07P | 5x Sterile Single IT Set | YES |
| 66-IT-08P | 5x Sterile Single IT Set | YES |
| 66-IT-09P | 5x Sterile Single IT Set | YES |
| 66-IT-1018 | Sterile Array Insertion Tube | YES |
| 66-IT-1019 | Sterile Lead Insertion Tube | YES |
| 66-IT-1028 | 28 cm Lead Insertion Tube | YES |
| 66-IT-11P | 5x Sterile Single IT Set | YES |
| 66-IT-13P | Ster. Insertion Tube Set 5x | YES |
| 66-IT-14P | 5x Sterile Single IT Set | YES |
| 66-IT-14S | Stereotactic Frame Insertion Tube Set 5x | YES |
| 66-IT-15P | mT insertion tube set w/stylet | YES |
| 66-IT-3000 | Box 5 Single Insertion Tubes | YES |
| 66-IT-4000 | Box of 5 Insertion Tubes | YES |
| 66-IT-4010S | NexFrame® Insertion Tube | YES |
| 66-IT-4015 | Single Electrode Insertion Tube Set 15mm above target 5x | YES |
| 66-IT-4015S | NexFrame® Insertion Tube Kit 5x | YES |
| 66-IT-40L | D.Zap Single Insertion | YES |
| 66-IT-7100 | Array Insertion Elect/Tube | YES |
| 66-IT-7140LI | Array Lead Insert Tubesw/Sty | YES |
| 66-IT-AO1P | IT/Stylet 162mm Sterile 5pk | YES |
| 66-IT-AO6P | IT/Stylet 165.65 mm Sterile 5pk | YES |
| 66-IT-AO11P | mT Insertion Tube with Stylet | YES |
| 66-IT-AR14P | mT Lead Insertion Tube w/ Stylet | YES |
| 66-IT-AR21P | Array Lead Insertion Tube w/ Stylet | YES |
| 66-IT-AR27P | mT Lead Insertion Tube w/ Stylet | YES |
| 66-IT-AR30P | Array Lead Insertion Tube w/ Stylet | YES |
| 66-IT-AR41P | microTargeting Insertion Tube w/Stylet | YES |
| 66-IT-AR42P | Array Insertion Tube w/Stylet 5x | YES |
| 66-IT-AR43P | Array Lead Insertion Tube w/Stylet 5x | YES |
| 66-IT-AR4P | microTargeting Lead Insertion | YES |
| 66-IT-AR5P | microTargeting Array Insertion | YES |
| 66-IT-AR6P | mT Lead Insertion Tube w/ Stylet | YES |
| 66-IT-BP8P | microTargeting Insertion | YES |
| 66-IT-CV2P |
IT/Stylet 74mm Sterile 5pk
|
YES |
| 66-IT-DB11P | microTargeting Single Ins. | YES |
| 66-IT-DB12P | Single Insertion Tube with Stylet At Target | YES |
| 66-IT-DB9P | microTargeting Single Insertion Tube | YES |
| 66-IT-DV1P | 5x Sterile Single IT Set | YES |
| 66-IT-FPP | Sterile Tandem Insertion Tube Set 5/pk | YES |
| 66-IT-KH1P | Nexframe/Nexdrive IT Set | YES |
| 66-IT-ME1P | mT insertion tube | YES |
| 66-IT-NX1P | 5x Sterile Array IT Set | YES |
| 66-ST-14P | DP Stylet 5x 204 mm | YES |
| 66-WP-BKS | Bilateral Surgical Kit | YES |
| 66-WP-IKS | WayPoint Implant Kit | YES |
| 66-IT-SG1P | mT insertion tube w/stylet | YES |
| 66-WP-SKS | WayPoint Platform Surgical Kit | YES |
| 66-ST-12P | mT DP stylet | YES |
| 70-CN-ET | Sterile STar Insertion Tube Extractors 5/pack | YES |
| 70-IT-1023 | Lead insertion tube set | YES |
| 70-IT-3007 | Box 5 Single Insertion Tubes | YES |
| 70-IT-7107 | Array Insertion Elect/Tube | YES |
| 70-IT-7147LI | Array Lead Insert Tubesw/Stylt | YES |
| 70-IT-7207 | STar Frame EC Adapter Insertion Tube Set, Sterile | YES |
| 70-IT-AR5P | Sterile STar Array Electrode Insertion Tubes Platform | YES |
| 70-IT-ARP | Sterile STar Array Electrode | YES |
| 70-ST-TS1P | STar Frame EC Adapter Track Stylet Set, Sterile | YES |
| 70-ZD-IKS | STar Inserter Kit | YES |
| MER-5000T | Box of 5mT Tungs. Electr.ARDB1 | YES |
| MTBPBP(DT1) | miT Backloaded Electrode Pt/Ir | YES |
| MTBWAP(JJ2) | microTargeting Electrode | YES |
| MTBWLP(ZK1) | microTargeting Electrode | YES |
| MTDPBP(AO)(AO1) | mT Electrode, Sterile 5 Pack Pt/Ir Differential, 1 Meg | YES |
| MTDPBP(AO)(AO9) | mT Electrode, Sterile 5-pack | YES |
| MTDPBP(BP)(BP7) | Platinum 1 Meg uE | YES |
| MTDPBP(LS)(LS3) | microTargeting Sterile Elect Differential, 1 Meg, 5 Pk | YES |
| MTDPBP(NS)(SL2) | mT Electrode, Sterile 5-pack | YES |
| MTDPBP(PS)(PS1) | Platinum 1 Meg uE | YES |
| MTDPLP(EP)(BP7) | Sterile DZap Platinum L Differential | YES |
| MTDPLP(EP)(BP8) | Sterile DZap Platinum L Differential | YES |
| MTDPLP(NS)(SL2) | mT Electrode, Sterile 5-pack | YES |
| MTDPLP(PA)(AR2) | microTargeting Sterile Microelectrode 5pk Dzap L | YES |
| MTDPLP(PA)(DB2) | Sterile DZap Platinum L | YES |
| MTDPLP(PA)(GH1) | PA mT electrode Pt/Ir Dzap L | YES |
| MTDPLP(PA)(MP1) | Nexframe / DZap Leadpoint / Array Sterile/ 5pk | YES |
| MTDPLT(EP)(BP7) | Sterile DZap Platinum L Differential | YES |
| MTDPLT(PA)(DB2) | Sterile DZap Platinum L | YES |
| MTDPXP(AO)(AO9) | mT Electrode, Sterile 5-pack | YES |
| MTDPXP(BP)(BP7) | Platinum uE Differential, | YES |
| MTDPZP(AO)(AO1) | mT Electrode, Sterile 5 Pack Pt/Ir Differential, 1 Meg DZAP | YES |
| MTDPZP(EP)(BP7) | Sterile DZap Platinum Differential | YES |
| MTDPZP(EP)(BP8) | Sterile DZap Platinum Differential | YES |
| MTDPZP(NS)(SL2) | mT Electrode, Sterile 5-pack | YES |
| MTDPZP(PA)(DB2) | Sterile DZap Platinum | YES |
| MTDPZP(PA)(GH1) | PA mT electrode Pt/Ir Dzap Z | YES |
| MTDPZP(PA)(MP1) | Nexframe / DZap / Array Sterile/ 5pk | YES |
| MTDPZT(EP)(BP7) | Sterile DZap Platinum Differential | YES |
| MTDPZT(PA)(DB2) | Sterile DZap Platinum | YES |
| MTDWBP(AO)(A10) | Shielded Tungsten 1 Meg uE | YES |
| MTDWBP(AO)(AO1) | mT Electrode, Sterile 5-pack | YES |
| MTDWBP(AO)(AO2) | NonShielded Tungsten, 1 meg uE | YES |
| MTDWBP(AO)(AO3) | NonShielded Tungsten, 1 meg | YES |
| MTDWBP(AR)(MP1) | mT Platform Tungsten 1 Meg uE, | YES |
| MTDWBP(BP)(B10) | microTargeting Sterile | YES |
| MTDWBP(BP)(BP6) | microTargeting Sterile differential Microelectrode | YES |
| MTDWBP(LS)(LS3) | microTargeting Sterile Elect Differential, 1 Meg, 5 Pk | YES |
| MTDWBP(SB)(SB2) | microTargeting Sterile differential Microelectrode | YES |
| MTDWBP(SP)(MP3) | microTargeting Sterile Microelectrode 5 pk 1 Meg | YES |
| MTDWLP(AO)(A10) | Shielded Tungsten DZap L | YES |
| MTDWLP(AO)(PT1) | Shielded Tungsten DZap L | YES |
| MTDWLP(BP)(B10) | microTargeting Sterile Microelectrode 5pk Dzap L | YES |
| MTDWLP(BP)(BP6) | Sterile DZap Tungsten L impedance | YES |
| MTDWLP(BP)(BP8) | Sterile DZap Tungsten L Impedance 5pk | YES |
| MTDWLP(BS)(FM2) | Sterile DZap Tungsten L Impedance | YES |
| MTDWLP(SP)(AR1) | Sterile DZap Tungsten Short Profile | YES |
| MTDWLP(SP)(MP3) | microTargeting Sterile Microelectrode 5 pk Dzap L | YES |
| MTDWLP(SP)(MP4) | Sterile DZap (L)Tungsten Short Profile | YES |
| MTDWLP(SS)(BP8) | Sterile DZap Tungsten Short Profile 5pk | YES |
| MTDWLT(AR)(AR2) | Sterile DZap Tungsten L | YES |
| MTDWLT(AR)(MP1) | Sterile DZap Tungsten | YES |
| MTDWLT(BP)(BP7) | Sterile Dzap Tungsten L | YES |
| MTDWZP(AO)(A10) | Shielded Tungsten DZap Z | YES |
| MTDWZP(AO)(AO2) | NonShielded Tungsten, D.Zap | YES |
| MTDWZP(AO)(AO3) | NonShielded Tungsten, D.ZAP | YES |
| MTDWZP(AO)(AO9) | mT Electrode, Sterile 5-pack | YES |
| MTDWZP(AO)(PT1) | Shielded Tungsten DZap Z | YES |
| MTDWZP(AO)(A11) | mT Electrode, Sterile 5-pack | YES |
| MTDWZP(AR)(AR7) | mT Electrode, Sterile 5-pack | YES |
| MTDWZP(AR)(DB1) | Sterile DZap Tungsten Differential | YES |
| MTDWZP(AR)(MP3) | Sterile DZap Tungsten Differential | YES |
| MTDWZP(AR)(MP7) | Platform Sterile DZap Z Tungsten 5pk | YES |
| MTDWZP(BP)(B10) | microTargeting Sterile Microelectrode 5pk Dzap Z | YES |
| MTDWZP(BP)(BP5) | microTargeting Sterile differential Microelectrode | YES |
| MTDWZP(BP)(BP8) | microTargeting Sterile D.Zap | YES |
| MTDWZP(BP)(BP11) | Frame Single Sterile DZap Z Tungsten 5pk | YES |
| MTDWZP(NS)(SK2) | mT Electrode, Sterile 5-pack | YES |
| MTDWZP(NS)(SL1) | mT Electrode, Sterile 5-pack | YES |
| MTDWZP(NS)(SL2) | mT Electrode, Sterile 5-pack | YES |
| MTDWZP(SB)(NS1) | mT Electrode, Sterile 5-pack | YES |
| MTDWZP(SP)(AR1) | Sterile DZap Tungsten Short Profile | YES |
| MTDWZP(SP)(AR5) | Sterile DZap Tungsten Short Profile | YES |
| MTDWZP(SP)(MP3) | microTargeting Sterile Microelectrode 5 pk Dzap Z | YES |
| MTDWZP(SP)(MP4) | Sterile DZap Tungsten Short Profile | YES |
| MTDWZP(SS)(BP8) | Sterile DZap Tungsten Short Profile 5pk | YES |
| MTDWZT(AR)(AR2) | Sterile DZap Tungsten | YES |
| MTDWZT(AR)(MP1) | Sterile DZap Tungsten | YES |
| MTDWZT(BP)(BP7) | Sterile DZap Tungsten | YES |
| MTSWBP(JN)(JN2) | Shielded mT Electrode | YES |
| MTSWLP(JN)(JN1) | mT Electrode Dzap L | YES |
| MTTWLP(ZK2) | Side by Side Microelectrode, Sterile | YES |
California’s Proposition 65, also called the Safe Drinking Water and Toxic Enforcement Act, was enacted in 1986. It is intended to help Californians make informed decisions about protecting themselves from chemicals known to cause cancer, birth defects, or other reproductive harm.
Ethelene Oxide is on the list of chemicals in Prop. 65.
The products included in this list are sterilized using EO and have residual levels of EO that are higher than what is allowed per PROP 65, therefore the following warning is required:
⚠ WARNING: This product can expose you to chemicals including Ethylene Oxide, which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information, go to www.P65Warnings.ca.gov.
The following products are manufactured by FHC and distributed by Medtronic:
| MDT Part ID | Description | Sterile |
| DB-2040 | Nexframe | YES |
| FC1004 | Sterile Drape Sleeves (PK/20) | YES |
| FC1018 | Array Elec. Insertion Tube w stylet Sterile Medtronic | YES |
| FC1019 | Lead Insertion Tube w/ Stylet, Sterile | YES |
| FC1020 | mT Microelectrode Cable | YES |
| FC1023 | 33cm Lead Insertion Tube Set | YES |
| FC1036 | Single Insertion Tube set 5x | YES |
| FC2001 | Sterile DZAP Array Insertion Electrode 5pk | YES |
| FC2002 | Sterile DZAP Single Insertion Electrode 5pk | YES |
| FC2003 | Sterile DZAP Single & Array Insertion Electrode 5pk | YES |
| FC2004 | Sterile DZAP Single & Array Insertion Electrode 5pk | YES |
| FC4000 | Box of 5 IT/electrodes kits | YES |
| FC4001 | DZAP Electrode Kit 5x Nexframe/Nexdrive/Leadpoint | YES |
| FC5000 | Box of 5 Pt Nexframe electrode | YES |
| FC7100 | Array Insertion Electrode/Tube w/ Stylet Kit | YES |
| FC7140LI | Array Lead Insert Tubes w/Stylet | YES |
| FC8009 | STar Array Electrode Insertion Tube with Stylet 5x | YES |
| FC8011 | STar Array Electrode Insertion Tube Extractor 5x | YES |
| FC9001 | STar Array Electrode Insertion Tube w/ Stylet 5x | YES |
| FC9002 | Lead Insertion Tube with Stylet 5x | YES |
| FC9003 | STar Single Electrode Insertion Tube Set 5x | YES |
| FM-4007 | Unibody™ Bone Fiducials (7mm) | YES |
| FM-4010 | Unibody™ Bone Fiducials (10mm) | YES |
| FM-4013 | Unibody™ Bone Fiducials (13mm) | YES |
| 22670 | Sterile Array Microelectrode, 5 pk | YES |
| 34680 | Sterile Single Microelectrode, 5pk | YES |
| KTF1001 | Sterile DZAP Single, Convenience Kit | YES |
| KTF1002 | Sterile DZAP STar Array, Convenience Kit | YES |
| MI-1000 | NEXDRIVE™ w/DIG | YES |
| MI-2000 | NEXDRIVE™ | YES |
| SR-10 | Nexframe Screws | YES |
| NP-1000 | Nexprobe® | YES |