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Pinnacle Bantam
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 2218-22-138Model PINNACLE Liner Trial
Identity
- Trade Name
- PINNACLE BANTAM EUDAMEDPINNACLE FDA UDI
- Generic Name
- Acetabulum prosthesis trial, prefabricated, reusable FDA UDI
- Device Name
- Liner Trial EUDAMEDPINNACLE BANTAM TRIAL LINER 38OD x 22.225ID 10 DEGREE FDA UDI
- Model / Reference
- PINNACLE Liner Trial EUDAMED2218-22-138 EUDAMEDFDA UDI
- Description
- PINNACLE BANTAM TRIAL LINER 38OD x 22.225ID 10 DEGREE FDA UDI
Identifiers
- Catalog Number
- 221822138 FDA UDI
- Primary DI / UDI-DI
- 10603295099772 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a001348C EUDAMED
- Direct Marketing DI
- 10603295099772 EUDAMED
- FDA Product Code
- HWT FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Acetabulum prosthesis trial, prefabricated, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4800 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
Pinnacle Bantam by DePuy Ireland UC — Class IIa — 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 | 0603295a001348C | 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 5fdd0bf9-9de0-4480-b710-a74a405669a6 61 fields · synced Jun 19, 2026
- FDA UDI df60b937-a2ba-4a6f-bea9-f3b5b40a23ae 35 fields · synced May 30, 2026