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Global Apg+
EUDAMEDFDA UDIClass I (EU MDR)
Ref 2230-00-025Model Surgical Instrument Handle, Non-Torque Limiting
Identity
- Trade Name
- GLOBAL APG+ EUDAMEDFDA UDI
- Generic Name
- Surgical instrument handle, non-torque-limiting FDA UDI
- Device Name
- Surgical Instrument Handle, Non-Torque Limiting EUDAMEDGLOBAL APG+ STRAIGHT HANDLE OUTER FDA UDI
- Model / Reference
- Surgical Instrument Handle, Non-Torque Limiting EUDAMED2230-00-025 EUDAMEDFDA UDI
- Description
- GLOBAL APG+ STRAIGHT HANDLE OUTER FDA UDI
Identifiers
- Catalog Number
- 223000025 FDA UDI
- Primary DI / UDI-DI
- 10603295102984 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a004328P EUDAMED
- Direct Marketing DI
- 10603295102984 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
Global Apg+ by DePuy Ireland UC — 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 | 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 4d70222d-722a-4f51-8efc-8d0f7c2a9c98 61 fields · synced Jun 1, 2026
- FDA UDI eb2af894-bea7-4a1d-9b38-04f3d2c3d72e 35 fields · synced May 30, 2026