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microTargeting™ Electrode and Insertion Tube
FDA UDIClass II (US FDA UDI)
by Fhc, Inc.
Identity
- Trade Name
- microTargeting™ Electrode and Insertion Tube FDA UDI
- Generic Name
- Depth electrode FDA UDI
- Device Name
- microTargeting single electrode insertion tubes and electrodes kit, 5x, Sterile for use with NexFrame and NexDrive or mT Drive. Each Box Contains: 2x MTDPBN(PA)(DB2) Electrode. 1x IT(DB3) Insertion Tube with Stylet. 1x PT(DB5) Spacer Tube. Individual Specifications: MTDPBN(PA)(DB2) - 249.2mm electrode length, 10mm tip expsure, 234.3mm protective tube length, 0.56mm od, 1.0 meg. RZAP IT(DB3) - 194mm length, 1.8mm od, 1.6mm id. PT(DB5) - 194mm length, 1.47mm od, 0.99mm id. FDA UDI
- Model / Reference
- FC4000-00115 FDA UDI
- Description
- microTargeting single electrode insertion tubes and electrodes kit, 5x, Sterile for use with NexFrame and NexDrive or mT Drive. Each Box Contains: 2x MTDPBN(PA)(DB2) Electrode. 1x IT(DB3) Insertion Tube with Stylet. 1x PT(DB5) Spacer Tube. Individual Specifications: MTDPBN(PA)(DB2) - 249.2mm electrode length, 10mm tip expsure, 234.3mm protective tube length, 0.56mm od, 1.0 meg. RZAP IT(DB3) - 194mm length, 1.8mm od, 1.6mm id. PT(DB5) - 194mm length, 1.47mm od, 0.99mm id. FDA UDI
Identifiers
- Catalog Number
- FC4000 FDA UDI
- Primary DI / UDI-DI
- 10873263001155 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
- Not 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
microTargeting™ Electrode and Insertion Tube by Fhc, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K011775 also covers:
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- 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.
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 81846100-4358-4268-b7e6-34eb19a75d3c 38 fields · synced Jun 8, 2026