← Back to catalogue
Duraloc Bantam
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 2241-44-501Model PINNACLE Liner Trial
Identity
- Trade Name
- DURALOC BANTAM EUDAMEDDURALOC FDA UDI
- Generic Name
- Acetabulum prosthesis trial, prefabricated, reusable FDA UDI
- Device Name
- Liner Trial EUDAMEDDURALOC BANTAM TRIAL LINER 10 DEGREES LW 22.225mm ID 44mm OD FDA UDI
- Model / Reference
- PINNACLE Liner Trial EUDAMED2241-44-501 EUDAMEDFDA UDI
- Description
- DURALOC BANTAM TRIAL LINER 10 DEGREES LW 22.225mm ID 44mm OD FDA UDI
Identifiers
- Catalog Number
- 224144501 FDA UDI
- Primary DI / UDI-DI
- 10603295107422 EUDAMEDFDA UDI
- Basic UDI-DI
- 0603295a001348C EUDAMED
- Direct Marketing DI
- 10603295107422 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
Duraloc 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DePuy Ireland UC
- EUDAMED SRN
- IE-MF-000007377
Sources (2)
- EUDAMED a5d080a8-6b54-4df3-bf25-4bb080fd00a9 61 fields · synced Jul 19, 2026
- FDA UDI b3520d01-1064-45c0-bc1c-79aa52637202 35 fields · synced May 29, 2026