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Disposable Skull Reference Drill Bit 1.1 mm for Bone Fixation Screw
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 52173
by Brainlab SE
Identity
- Trade Name
- Disposable Skull Reference Drill Bit 1.1 mm for Bone Fixation Screw EUDAMEDFDA UDI
- Generic Name
- Electromagnetic/optical surgical navigation device tracking system FDA UDI
- Device Name
- Disposable Skull Reference Drill Bit 1.1 mm for Bone Fixation Screw EUDAMED
- Model / Reference
- 52173 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056481144692 EUDAMEDFDA UDI
- Basic UDI-DI
- 4056481SkullRefDrillBitRJ EUDAMED
- Direct Marketing DI
- 04056481144692 EUDAMED
- FDA Product Code
- PGW FDA UDIHAW FDA UDI
- EMDN Code
- Z12011485 SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Electromagnetic/optical surgical navigation device tracking 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
Yes
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
No
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Disposable Skull Reference Drill Bit 1.1 mm for Bone Fixation Screw by Brainlab SE — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 4056481SkullRefDrillBitRJ | 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 294a59b5-b335-4f0d-b5ca-749f139ae879 61 fields · synced Jun 18, 2026
- FDA UDI f7c2295e-d206-4f97-859a-f29d6e350fa0 33 fields · synced May 29, 2026