Identity
- Trade Name
- STar™ Drive XL Frame Adapter FDA UDI
- Generic Name
- Neurosurgical micro targeting drive FDA UDI
- Device Name
- STar(TM) Drive XL Frame Adapter for use with Radionics CRW stereotactic frame FDA UDI
- Model / Reference
- 70-FA-RD-XL-00225 FDA UDI
- Description
- STar(TM) Drive XL Frame Adapter for use with Radionics CRW stereotactic frame FDA UDI
Identifiers
- Catalog Number
- 70-FA-RD-XL FDA UDI
- Primary DI / UDI-DI
- 00873263002254 FDA UDI
- 510(k) Number
- K121950 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
- 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Neurosurgical micro targeting drive
STar™ Drive XL Frame Adapter by Fhc, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Neurosurgical micro targeting drive.
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- microTargeting™ Directional Lead Holder — FHC, INC. · Class II
- STar™ Drive Frame Adapter — FHC, INC. · Class II
- microTargeting™ Matrix Guide Bushings — FHC, INC. · Class II
- STar™ Drive Frame Adapter — FHC, INC. · Class II
- microTargeting™ Controller — FHC, INC. · Class II
Cleared under the same submission
K121950 also covers:
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 84c06e52-6fe6-4b58-ae48-5105e5271d17 37 fields · synced May 30, 2026