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Drill Bit 3.2 mm Depth Control (200 mm)
FDA UDIEUDAMEDClass II (US FDA UDI)
by Brainlab AG
Identity
- Trade Name
- Drill Bit 3.2 mm Depth Control (200 mm) FDA UDI
- Generic Name
- Robotic surgical navigation system FDA UDI
- Model / Reference
- 41839-37 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056481141486 FDA UDI
- FDA Product Code
- HAW FDA UDIOLO 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
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
Drill Bit 3.2 mm Depth Control (200 mm) by Brainlab AG — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Brainlab AG
Sources (2)
- FDA UDI 002c4c8b-4678-4c66-b03c-4ea25c0e06ff 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026