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Global Advantage
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 2128-61-007Model Fluted Surgical Drill Bit, Reusable
Identity
- Trade Name
- GLOBAL ADVANTAGE EUDAMEDFDA UDI
- Generic Name
- Fluted surgical drill bit, reusable FDA UDI
- Device Name
- Fluted Surgical Drill Bit, Reusable EUDAMEDGLOBAL ADVANTAGE PILOT HOLE/KEEL DRILL BIT FDA UDI
- Model / Reference
- Fluted Surgical Drill Bit, Reusable EUDAMED2128-61-007 EUDAMEDFDA UDI
- Description
- GLOBAL ADVANTAGE PILOT HOLE/KEEL DRILL BIT FDA UDI
Identifiers
- Catalog Number
- 212861007 FDA UDI
- Primary DI / UDI-DI
- 10603295089292 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a0053694 EUDAMED
- FDA Product Code
- HTW FDA UDI
- EMDN Code
- L090999 ORTHOPAEDIC SURGERY CUTTING INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Fluted surgical drill bit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Ireland 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
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Yes
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
Category: Bone cutting forceps, reusable
Global Advantage by DePuy Ireland UC — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 0603295a0053694 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- DePuy Ireland UC
- EUDAMED SRN
- IE-MF-000007377
Sources (2)
- EUDAMED ccc88067-856f-4e66-a415-1cd2a15b2e44 61 fields · synced Jul 18, 2026
- FDA UDI 06679374-256a-4a75-83b8-59028faaa76b 35 fields · synced May 30, 2026