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Drill Bit 2.0 Mm Depth Control 0-60 Mm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 41839-38
by Brainlab SE
Identity
- Trade Name
- DRILL BIT 2.0 MM DEPTH CONTROL 0-60 MM EUDAMEDFDA UDI
- Generic Name
- Fluted surgical drill bit, reusable FDA UDI
- Device Name
- Drill Bit EUDAMED
- Model / Reference
- 41839-38 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056481145835 EUDAMEDFDA UDI
- Basic UDI-DI
- 4056481DrillAZ EUDAMED
- Direct Marketing DI
- 04056481145835 EUDAMED
- 510(k) Number
- K240701 FDA UDI
- FDA Product Code
- OLO FDA UDI
- EMDN Code
- Z12130580 MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Fluted surgical drill bit, reusable 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Drill Bit 2.0 Mm Depth Control 0-60 Mm 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 d8ca1d5e-f13a-4514-97a4-98da330d686d 61 fields · synced Jul 17, 2026
- FDA UDI 4ebe1aef-28b4-4796-9a1e-ee0f232e7e2d 33 fields · synced May 30, 2026