Identity
- Trade Name
- OsteoFab Suture Anchor FDA UDI
- Generic Name
- Bone awl, reusable FDA UDI
- Device Name
- 4mm OsteoFab Suture Anchor Awl FDA UDI
- Model / Reference
- INS002-01-003 FDA UDI
- Description
- 4mm OsteoFab Suture Anchor Awl FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850004435038 FDA UDI
- FDA Product Code
- HWJ FDA UDI
- GMDN Term
- Bone awl, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone awl, reusable
OsteoFab Suture Anchor by Oxford Performance Materials — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone awl, reusable.
- Vital™ MIS Spinal Fixation System — BIOMET SPINE LLC · Class I
- Trigen — Smith & Nephew, Inc. · Class I
- Navigated Instruments — EVOLUTION SPINE, LLC · Class II
- PYRENEES Cervical Plate System — K2M, INC. · Class I
- Awl — SIGNATURE ORTHOPAEDICS PTY LTD · Class I
- CONMED — Conmed Corporation · Class I
- Sklar® — Sklar Corporation · Class I
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Oxford Performance Materials
Sources (1)
- FDA UDI 659e1bf3-2dbb-4032-baf6-7324d01c1d30 34 fields · synced May 30, 2026