Identity
- Trade Name
- DURALOC FDA UDI
- Generic Name
- Acetabular shell FDA UDI
- Device Name
- DURALOC SHELL SECTOR 64mm OD CEMENTLESS FDA UDI
- Model / Reference
- 1245-80-057 FDA UDI
- Description
- DURALOC SHELL SECTOR 64mm OD CEMENTLESS FDA UDI
Identifiers
- Catalog Number
- 124580057 FDA UDI
- Primary DI / UDI-DI
- 10603295019664 FDA UDI
- FDA Product Code
- JDI FDA UDILPH FDA UDI
- GMDN Term
- Acetabular shell FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3350 FDA UDI888.3358 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Acetabular shell
Duraloc by Depuy (ireland) — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K951301 also covers:
- DURALOC — DEPUY (IRELAND)
- DURALOC — DEPUY (IRELAND)
- DURALOC — DEPUY (IRELAND)
- DURALOC — DEPUY (IRELAND)
- DURALOC — DEPUY (IRELAND)
- DURALOC — DEPUY (IRELAND)
- DURALOC — DEPUY (IRELAND)
- DURALOC — DEPUY (IRELAND)
- DURALOC — DEPUY ORTHOPAEDICS, INC.
- DURALOC — DEPUY ORTHOPAEDICS, INC.
- DURALOC — DEPUY ORTHOPAEDICS, INC.
- DURALOC — DEPUY ORTHOPAEDICS, INC.
K952740 also covers:
K961186 also covers:
- DURALOC — DEPUY (IRELAND)
- DURALOC — DEPUY (IRELAND)
- DURALOC — DEPUY (IRELAND)
- DURALOC — DEPUY (IRELAND)
- DURALOC — DEPUY (IRELAND)
- DURALOC — DEPUY (IRELAND)
- DURALOC — DEPUY (IRELAND)
- DURALOC — DEPUY (IRELAND)
- DURALOC — DEPUY (IRELAND)
- DURALOC — DEPUY ORTHOPAEDICS, INC.
- DURALOC — DEPUY ORTHOPAEDICS, INC.
- DURALOC — DEPUY ORTHOPAEDICS, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Depuy (ireland)
Sources (1)
- FDA UDI d81ac159-5510-4b3e-83eb-b8a8b1862639 36 fields · synced Jun 6, 2026