Identity
- Trade Name
- microTargeting™ Procedure Kit FDA UDI
- Generic Name
- Depth electrode FDA UDI
- Device Name
- microTargeting Platform Procedure Consumables Kit, 1x, sterile, for use with mT or STar Drive, mT Platform and Guideline 4000 LP+. Contains: 44975L: D.ZAP Tungsten Differential Electrode - - 220.72mm electrode length, 10mm differential, 205.72mm protective tube length, DZAP(L) 1Meg, 0.55mm od. 66-DA-SD: Sterile Drape Sleeve for motor 66-EL-LP: Patient Lead for Guideline 4000 LP+ 66-IT-03P: Sterile Single Insertion Tube Set - IT(MP1) - 184.1mm tube length, 1.83mm od, 1.6mm id with Stylet PT(MP1) - Diameter reduction tube 0.58mm id FDA UDI
- Model / Reference
- KT-PPK-S-00366 FDA UDI
- Description
- microTargeting Platform Procedure Consumables Kit, 1x, sterile, for use with mT or STar Drive, mT Platform and Guideline 4000 LP+. Contains: 44975L: D.ZAP Tungsten Differential Electrode - - 220.72mm electrode length, 10mm differential, 205.72mm protective tube length, DZAP(L) 1Meg, 0.55mm od. 66-DA-SD: Sterile Drape Sleeve for motor 66-EL-LP: Patient Lead for Guideline 4000 LP+ 66-IT-03P: Sterile Single Insertion Tube Set - IT(MP1) - 184.1mm tube length, 1.83mm od, 1.6mm id with Stylet PT(MP1) - Diameter reduction tube 0.58mm id FDA UDI
Identifiers
- Catalog Number
- KT-PPK-S FDA UDI
- Primary DI / UDI-DI
- 00873263003664 FDA UDI
- FDA Product Code
- HAW FDA UDIGZL FDA UDI
- GMDN Term
- Depth electrode FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI882.1330 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Patient surgical drape, single-useDepth electrodeIntracerebral cannula, implantable
microTargeting™ Procedure Kit by Fhc, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K011775 also covers:
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- microTargeting™ Array Electrode Carrier and Clamp — FHC, INC.
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- microTargeting™ Frame Adapter — FHC, INC.
- microTargeting™ Insertion Tube — FHC, INC.
- microTargeting™ Insertion Tube — FHC, INC.
- microTargeting™ Insertion Tube — FHC, INC.
- microTargeting™ Insertion Tube — FHC, INC.
- microTargeting™ Insertion Tube — FHC, INC.
K011992 also covers:
- Electrode Depth Stop Adapter — FHC, INC.
- Frame Adapter for Leibinger RM™ — FHC, INC.
- LeadLoc Depth Stop — FHC, INC.
- LeadLoc Depth Stop — FHC, INC.
- MacroStim Interface (MSI) — FHC, INC.
- microTargeting™ Array Clamp — FHC, INC.
- microTargeting™ Array Electrode Carrier Set — FHC, INC.
- microTargeting™ Cleaning Brushes — FHC, INC.
- microTargeting™ Controller — FHC, INC.
- microTargeting™ Controller — FHC, INC.
- microTargeting™ Controller Handheld Remote Control — FHC, INC.
- microTargeting™ Controller Power Assist System — FHC, INC.
K071364 also covers:
- Guideline™ 4000 — FHC, INC.
- Lead Adapter, For use with Multi-Lead Trial Cable to Guideline System — FHC, INC.
- microTargeting ™ Lead Adapter — FHC, INC.
- microTargeting™ Electrode Cable — FHC, INC.
- microTargeting™ Electrode Cable — FHC, INC.
- microTargeting™ Electrode Cable — FHC, INC.
- microTargeting™ Electrode Cable — FHC, INC.
- microTargeting™ Electrode Cable — FHC, INC.
- microTargeting™ Guideline 4000 LP+™ — FHC, INC.
- microTargeting™ Guideline 4000 LP+™ Breakout Box — FHC, INC.
- microTargeting™ Guideline 4000 LP+™ Cart — FHC, INC.
- microTargeting™ Guideline 4000 LP+™ Channel Card — FHC, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Fhc, Inc.
Sources (1)
- FDA UDI 01f77907-39d7-4565-875d-0e9bf8138f33 37 fields · synced May 30, 2026