Identity
- Trade Name
- DURALOC FDA UDI
- Generic Name
- Acetabular shell FDA UDI
- Device Name
- DURALOC DYNAMIC LOCKING RING 48mm FDA UDI
- Model / Reference
- 1249-48-000 FDA UDI
- Description
- DURALOC DYNAMIC LOCKING RING 48mm FDA UDI
Identifiers
- Catalog Number
- 124948000 FDA UDI
- Primary DI / UDI-DI
- 10603295019749 FDA UDI
- FDA Product Code
- LPH FDA UDI
- GMDN Term
- Acetabular shell FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3358 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 Orthopaedics, Inc. — 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 (IRELAND)
- DURALOC — DEPUY ORTHOPAEDICS, INC.
- DURALOC — DEPUY ORTHOPAEDICS, INC.
- DURALOC — DEPUY ORTHOPAEDICS, INC.
K951674 also covers:
- DURALOC — DEPUY ORTHOPAEDICS, INC.
- DURALOC — DEPUY ORTHOPAEDICS, INC.
- DURALOC — DEPUY ORTHOPAEDICS, INC.
- DURALOC — DEPUY ORTHOPAEDICS, INC.
- DURALOC — DEPUY ORTHOPAEDICS, INC.
- DURALOC — DEPUY ORTHOPAEDICS, INC.
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Depuy Orthopaedics, Inc.
Sources (1)
- FDA UDI c91a798a-4ed1-4273-86c4-9fd8cd7f119e 36 fields · synced Jun 8, 2026