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Drill Guide Tube (2.0 mm)
EUDAMEDFDA UDIClass I (EU MDR)
Ref 51839-20Model 51839-45
by Brainlab SE
Identity
- Trade Name
- Drill Guide Tube (2.0 mm) EUDAMEDDrill Guide Tube (2.0 mm) FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- Drill Guide Tube (4.5 mm) EUDAMED
- Model / Reference
- 51839-45 EUDAMED51839-20 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056481144821 EUDAMEDFDA UDI
- Basic UDI-DI
- 4056481DrillGuideTubeCW EUDAMED
- Direct Marketing DI
- 04056481144821 EUDAMED
- 510(k) Number
- K240701 FDA UDI
- FDA Product Code
- OLO FDA UDI
- EMDN Code
- Z12011480 SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Surgical drill guide, reusable FDA UDI
Classification
- Device Class
- Class I 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
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
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
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 Guide Tube (2.0 mm) by Brainlab SE — Class I — 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 | 4056481DrillGuideTubeCW | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Brainlab SE
- EUDAMED SRN
- DE-MF-000006183
Sources (2)
- EUDAMED c7c43abe-48ac-4f3e-9368-6515447f8596 61 fields · synced Jul 11, 2026
- FDA UDI e0bfbaab-8693-41a4-b635-59ac5dde021b 33 fields · synced May 30, 2026