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Drill Bit Cranial 2.1/4.0
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 56405-04
by Brainlab SE
Identity
- Trade Name
- Drill Bit Cranial 2.1/4.0 EUDAMEDFDA UDI
- Generic Name
- Fluted surgical drill bit, single-use FDA UDI
- Device Name
- Drill Bit Cranial EUDAMED
- Model / Reference
- 56405-04 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056481143145 EUDAMEDFDA UDI
- Basic UDI-DI
- 4056481DrillCranial9C EUDAMED
- Direct Marketing DI
- 04056481143145 EUDAMED
- FDA Product Code
- HAW FDA UDI
- EMDN Code
- Z12011485 SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Fluted surgical drill bit, single-use 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
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
Microwave Radiation FDA UDI
Drill Bit Cranial 2.1/4.0 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 | 4056481DrillCranial9C | 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 07f52b3e-5ba3-49c1-8142-5f168bbc4a7d 61 fields · synced Jun 19, 2026
- FDA UDI 006c2586-51ba-4e2b-bed3-6abe4200f630 33 fields · synced May 30, 2026