Identity
- Trade Name
- microTargeting™ Single Procedure Kit FDA UDI
- Generic Name
- Depth electrode FDA UDI
- Device Name
- microTargeting Single Procedure Kit, with microElectrode, tubes, sterile drape sleeve and cable. Contains: IT(BP2): Insertion Tube. 2x MTDWLN(BP)(BP7): microTargeting Electrode. PT(BP2): Protective Tube. Sterile Drape Sleeve for microTargeting motor FC1020 Electrode Lead Individual Specifications: IT(BP2) - 183mm tube length, 1.829mm OD, 1.6mm ID, 184mm stylet (not including collar). MTDWLN(BP)(BP7) - 271.4mm electrode length, 10mm differential, 256.4mm protective tube length, 0.77mm OD. 1Meg DZAP(L) PT(PB2) - 181mm tube length, 1.47mm OD, 0.99mm ID OD: 0.77mm FDA UDI
- Model / Reference
- KTF1001-00757 FDA UDI
- Description
- microTargeting Single Procedure Kit, with microElectrode, tubes, sterile drape sleeve and cable. Contains: IT(BP2): Insertion Tube. 2x MTDWLN(BP)(BP7): microTargeting Electrode. PT(BP2): Protective Tube. Sterile Drape Sleeve for microTargeting motor FC1020 Electrode Lead Individual Specifications: IT(BP2) - 183mm tube length, 1.829mm OD, 1.6mm ID, 184mm stylet (not including collar). MTDWLN(BP)(BP7) - 271.4mm electrode length, 10mm differential, 256.4mm protective tube length, 0.77mm OD. 1Meg DZAP(L) PT(PB2) - 181mm tube length, 1.47mm OD, 0.99mm ID OD: 0.77mm FDA UDI
Identifiers
- Catalog Number
- KTF1001 FDA UDI
- Primary DI / UDI-DI
- 00873263007570 FDA UDI
- FDA Product Code
- GZL FDA UDIHAW FDA UDI
- GMDN Term
- Depth electrode FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1330 FDA UDI882.4560 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
Ethylene Oxide FDA UDI
MR Unsafe FDA UDI
Category: Patient surgical drape, single-useDepth electrodeIntracerebral cannula, nonimplantable, single-use
microTargeting™ Single 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:
- 33 cm Lead Insertion Tube Set — FHC, INC.
- Microtargeting ™ STar Drive Adapter — FHC, INC.
- STar™ Drive Insertion Tube Extractor — FHC, INC.
- microTargeting Insertion Tube — FHC, INC.
- microTargeting™ Array Electrode Carrier and Clamp — FHC, INC.
- microTargeting™ Electrode and Insertion Tube — FHC, INC.
- 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.
K033173 also covers:
- Insertion Tube — FHC, INC.
- microTargeting™ Array Electrode — FHC, INC.
- microTargeting™ Array Electrode — FHC, INC.
- microTargeting™ Differential Electrode — FHC, INC.
- microTargeting™ Electrode — FHC, INC.
- microTargeting™ Electrode — FHC, INC.
- microTargeting™ Electrode — FHC, INC.
- microTargeting™ Electrode — FHC, INC.
- microTargeting™ Electrode — FHC, INC.
- microTargeting™ Electrode — FHC, INC.
- microTargeting™ Electrode — FHC, INC.
- microTargeting™ Electrode — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fhc, Inc.
Sources (1)
- FDA UDI 63ecf005-f962-4b67-a46d-31c319b1bbb7 37 fields · synced Jun 1, 2026