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Global Apg+
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 2236-10-010Model Bone-Resection Orthopaedic Reamer, Reusable
Identity
- Trade Name
- GLOBAL APG+ EUDAMEDFDA UDI
- Generic Name
- Bone-resection orthopaedic reamer, reusable FDA UDI
- Device Name
- Bone-Resection Orthopaedic Reamer, Reusable EUDAMEDGLOBAL APG+ ACCESS REAMER SIZE 48 RU FDA UDI
- Model / Reference
- Bone-Resection Orthopaedic Reamer, Reusable EUDAMED2236-10-010 EUDAMEDFDA UDI
- Description
- GLOBAL APG+ ACCESS REAMER SIZE 48 RU FDA UDI
Identifiers
- Catalog Number
- 223610010 FDA UDI
- Primary DI / UDI-DI
- 10603295106074 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a005338W EUDAMED
- Direct Marketing DI
- 10603295106074 EUDAMED
- FDA Product Code
- HTO FDA UDI
- EMDN Code
- L091102 ORTHOPAEDIC PROSTHESES REAMERS AND BURS, REUSABLE EUDAMED
- GMDN Term
- Bone-resection orthopaedic reamer, 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: Acetabular orthopaedic reamer
Global Apg+ 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 | 0603295a005338W | 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 7c6e9a6c-5f35-42bc-8786-bbfdea5e1dba 61 fields · synced Jul 11, 2026
- FDA UDI a72984e4-89c8-4b2f-adb6-37cafbf5da21 35 fields · synced May 30, 2026