Identity
- Trade Name
- Oxford Partial Knee System FDA UDI
- Generic Name
- Abdominal/ENT/orthopaedic surgical probe, reusable FDA UDI
- Device Name
- Domed Lateral Feeler Gauge FDA UDI
- Model / Reference
- 32-422061 FDA UDI
- Description
- Domed Lateral Feeler Gauge FDA UDI
Identifiers
- Catalog Number
- 32-422061 FDA UDI
- Primary DI / UDI-DI
- 05019279113583 FDA UDI
- PMA Number
- P010014 FDA UDI
- FDA Product Code
- NRA FDA UDI
- GMDN Term
- Abdominal/ENT/orthopaedic surgical probe, reusable FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Abdominal/ENT/orthopaedic surgical probe, reusable
Oxford Partial Knee System by Biomet Uk Ltd — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Abdominal/ENT/orthopaedic surgical probe, reusable.
- DRM Thoracic Pedicle Feeler 1 — Captiva Spine · Class I
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- ISOLA — Depuy Spine, Inc. · Class I
- Medtronic Resuable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- Invictus — ALPHATEC SPINE, INC. · Class I
- Optima™ Spinal System — CG MedTech Co., Ltd. · Class I
- General Instruments — ALPHATEC SPINE, INC. · Class I
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
Cleared under the same submission
P010014 also covers:
- Oxford Partial Knee System — Biomet Orthopedics, Inc.
- Oxford Partial Knee System — Biomet Orthopedics, Inc.
- Oxford Partial Knee System — Biomet Orthopedics, Inc.
- Oxford Partial Knee System — Biomet Uk Ltd
- Oxford Partial Knee System — Biomet Uk Ltd
- Oxford Partial Knee System — Biomet Uk Ltd
- Oxford Partial Knee System — Biomet Uk Ltd
- Oxford Partial Knee System — Biomet Uk Ltd
- Oxford Partial Knee System — Biomet Uk Ltd
- Oxford Partial Knee System — Biomet Uk Ltd
- Oxford Partial Knee System — Biomet Uk Ltd
- Oxford Partial Knee System — Biomet Uk Ltd
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 III | Pending data |
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Manufacturer
- Manufacturer
- Biomet Uk Ltd
Sources (1)
- FDA UDI da06a6a6-74e8-4088-8d35-83ddf01d9208 37 fields · synced Jun 8, 2026