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Instr. Adapter Clamp (Starlink), Size Xl
FDA UDIClass II (US FDA UDI)
by Brainlab SE
Identity
- Trade Name
- Instr. Adapter Clamp (Starlink), Size Xl FDA UDI
- Generic Name
- Robotic surgical navigation system FDA UDI
- Model / Reference
- 55004 FDA UDI
Identifiers
- Catalog Number
- 55004 FDA UDI
- Primary DI / UDI-DI
- 04056481005399 FDA UDI
- 510(k) Number
- K092467 FDA UDI
- FDA Product Code
- HAW FDA UDI
- GMDN Term
- Robotic surgical navigation system 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
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Instr. Adapter Clamp (Starlink), Size Xl by Brainlab SE — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K092467 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 |
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Manufacturer
- Manufacturer
- Brainlab SE
Sources (1)
- FDA UDI c6142be1-e80a-4196-86f3-0fc85dd2c895 36 fields · synced May 31, 2026