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Global Advantage+
EUDAMEDFDA UDIClass I (EU MDR)
Ref 2128-01-850Model Surgical Instrument Handle, Non-Torque Limiting
Identity
- Trade Name
- GLOBAL ADVANTAGE+ EUDAMEDGLOBAL ADVANTAGE FDA UDI
- Generic Name
- Surgical instrument handle, non-torque-limiting FDA UDI
- Device Name
- Surgical Instrument Handle, Non-Torque Limiting EUDAMEDGLOBAL ADVANTAGE + BROACH HANDLE FDA UDI
- Model / Reference
- Surgical Instrument Handle, Non-Torque Limiting EUDAMED2128-01-850 EUDAMEDFDA UDI
- Description
- GLOBAL ADVANTAGE + BROACH HANDLE FDA UDI
Identifiers
- Catalog Number
- 212801850 FDA UDI
- Primary DI / UDI-DI
- 10603295088158 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a004328P EUDAMED
- Direct Marketing DI
- 10603295088158 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L091104 ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE EUDAMED
- GMDN Term
- Surgical instrument handle, non-torque-limiting FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA 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
Yes
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: Orthopaedic implant impactor, reusable
Global Advantage+ by DePuy Ireland UC — Class I — 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 | 0603295a004328P | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- DePuy Ireland UC
- EUDAMED SRN
- IE-MF-000007377
Sources (2)
- EUDAMED b868cb6e-26f1-47d0-986b-be9370eabf2d 61 fields · synced May 30, 2026
- FDA UDI 04107818-599a-4c11-899c-1b36f2fa08f2 35 fields · synced May 30, 2026