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microTargeting™ STar™ Electrode Carrier
FDA UDIClass II (US FDA UDI)
by Fhc, Inc.
Identity
- Trade Name
- microTargeting™ STar™ Electrode Carrier FDA UDI
- Generic Name
- Neurosurgical micro targeting drive FDA UDI
- Device Name
- STar(TM) Drive Single Electrode Insertion Locking Carrier, 2x, can also be used with the microTargeting(TM) Drive FDA UDI
- Model / Reference
- FC8010-00085 FDA UDI
- Description
- STar(TM) Drive Single Electrode Insertion Locking Carrier, 2x, can also be used with the microTargeting(TM) Drive FDA UDI
Identifiers
- Catalog Number
- FC8010 FDA UDI
- Primary DI / UDI-DI
- 10873263000851 FDA UDI
- 510(k) Number
- K092562 FDA UDI
- FDA Product Code
- HAW FDA UDI
- GMDN Term
- Neurosurgical micro targeting drive FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
microTargeting™ STar™ Electrode Carrier by Fhc, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K092562 also covers:
- Cable Management System — FHC, INC.
- Lower Lead Depth Stop — FHC, INC.
- STar™ Drive Accesories Kit — FHC, INC.
- STar™ Drive Electrode Carrier — FHC, INC.
- STar™ Drive Electrode Carrier — FHC, INC.
- STar™ Drive Electrode Carrier — FHC, INC.
- STar™ Drive Electrode Carrier — FHC, INC.
- STar™ Drive Electrode Carrier — FHC, INC.
- STar™ Drive Frame Adapter — FHC, INC.
- STar™ Drive Frame Adapter — FHC, INC.
- STar™ Drive Frame Adapter — FHC, INC.
- STar™ Drive Frame Adapter — 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 ba187ccd-954e-40f1-8dc3-eca4582177e5 38 fields · synced May 30, 2026