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Drill Bit 4.5 Mm Ao Shank
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 41839-45A
by Brainlab SE
Identity
- Trade Name
- DRILL BIT 4.5 MM AO SHANK EUDAMEDFDA UDI
- Generic Name
- Robotic surgical navigation system FDA UDI
- Device Name
- Drill Bit EUDAMED
- Model / Reference
- 41839-45A EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056481143190 EUDAMEDFDA UDI
- Basic UDI-DI
- 4056481DrillAZ EUDAMED
- Direct Marketing DI
- 04056481143190 EUDAMED
- 510(k) Number
- K212245 FDA UDI
- FDA Product Code
- OLO FDA UDI
- EMDN Code
- Z12130580 MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Robotic surgical navigation system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Moist Heat or Steam Sterilization FDA UDI
Drill Bit 4.5 Mm Ao Shank by Brainlab SE — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4056481DrillAZ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Brainlab SE
- EUDAMED SRN
- DE-MF-000006183
Sources (2)
- EUDAMED 59256350-00bc-4849-a7e4-83f22638c2a2 61 fields · synced Jun 18, 2026
- FDA UDI 81fe8064-f6f2-444e-b1e0-2d87f610bfa1 33 fields · synced May 30, 2026