Identity
- Trade Name
- Paragon 28 Bone Wedge System FDA UDI
- Generic Name
- Surgical implant/trial-implant/sizer holder, reusable FDA UDI
- Device Name
- AO Cotton Wedge Trial Spacer 16-4.5 FDA UDI
- Model / Reference
- AOCW-TRL-16-4.5 FDA UDI
- Description
- AO Cotton Wedge Trial Spacer 16-4.5 FDA UDI
Identifiers
- Catalog Number
- AOCW-TRL-16-4.5 FDA UDI
- Primary DI / UDI-DI
- 00889795118523 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Surgical implant/trial-implant/sizer holder, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 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
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 Unsafe FDA UDI
Category: Surgical implant/trial-implant/sizer holder, reusable
Paragon 28 Bone Wedge System by Paragon 28 — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical implant/trial-implant/sizer holder, reusable.
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- BENCOX THR System — Corentec Co., Ltd · Class II
- DISTAL TIBIAL PLATE HANDLE, RIGHT — Biomet Orthopedics, 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 II | Pending data |
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Manufacturer
- Manufacturer
- Paragon 28
Sources (1)
- FDA UDI a496e046-7ba9-4366-a346-29bdb33f76db 34 fields · synced May 31, 2026