Identity
- Trade Name
- R3 FDA UDI
- Generic Name
- Non-constrained polyethylene acetabular liner FDA UDI
- Device Name
- R3 0 DEGREE +4 ACETABULAR LINER 44MM INNER DIAMETER X 66-70MM OUTER DIAMETER FDA UDI
- Model / Reference
- 71330014 FDA UDI
- Description
- R3 0 DEGREE +4 ACETABULAR LINER 44MM INNER DIAMETER X 66-70MM OUTER DIAMETER FDA UDI
Identifiers
- Catalog Number
- 71330014 FDA UDI
- Primary DI / UDI-DI
- 03596010651921 FDA UDI
- FDA Product Code
- MBL FDA UDI
- GMDN Term
- Non-constrained polyethylene acetabular liner 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: Non-constrained polyethylene acetabular liner
R3 by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Non-constrained polyethylene acetabular liner.
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Cleared under the same submission
K093363 also covers:
- OXINIUM — Smith & Nephew, Inc.
- OXINIUM — Smith & Nephew, Inc.
- R3 — Smith & Nephew, Inc.
- R3 — Smith & Nephew, Inc.
- R3 — Smith & Nephew, Inc.
- R3 — Smith & Nephew, Inc.
- R3 — Smith & Nephew, Inc.
- R3 — Smith & Nephew, Inc.
- R3 — Smith & Nephew, Inc.
- R3 — Smith & Nephew, Inc.
- R3 — Smith & Nephew, Inc.
- R3 — Smith & Nephew, Inc.
K211176 also covers:
- BUCK — Smith & Nephew, Inc.
- Conquest FX — Smith & Nephew, Inc.
- Contour — Smith & Nephew, Inc.
- ECHELON — Smith & Nephew, Inc.
- ECHELON — Smith & Nephew, Inc.
- ECHELON — Smith & Nephew, Inc.
- ECHELON — Smith & Nephew, Inc.
- POLARCUP — Smith & Nephew, Inc.
- POLARCUP — Smith & Nephew, Inc.
- POLARCUP — Smith & Nephew, Inc.
- POLARCUP — Smith & Nephew, Inc.
- POLARCUP — Smith & Nephew, 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
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI 343cc93a-70b9-4460-b9b2-4f5f44f406c7 36 fields · synced Jun 8, 2026