Identity
- Trade Name
- PolyPrep FDA UDI
- Generic Name
- Bone curette, single-use FDA UDI
- Device Name
- Curette 4mm (Sterile) FDA UDI
- Model / Reference
- CD-PP-1004-S FDA UDI
- Description
- Curette 4mm (Sterile) FDA UDI
Identifiers
- Catalog Number
- CD-PP-1004-S FDA UDI
- Primary DI / UDI-DI
- 00840124512887 FDA UDI
- FDA Product Code
- HTF FDA UDI
- GMDN Term
- Bone curette, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Bone curette, single-use
PolyPrep by Fusion Orthopedics, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone curette, single-use.
- MACI Arthroscopic Instruments — Vericel Corporation · Class I
- Neo Medical Cage kit — Neo Medical Inc. · Class I
- CURRETTE — DR.FRIGZ INTERNATIONAL(PVT)LTD, · Class I
- Instrapac — ROBINSON HEALTHCARE LIMITED · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Instrapac — ROBINSON HEALTHCARE LIMITED · Class I
- MACI Arthroscopic Instruments — Vericel Corporation · Class I
- Neo Medical Cage kit — Neo Medical 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
- Fusion Orthopedics, Llc
Sources (1)
- FDA UDI df3f8aa5-0611-4fb5-a65d-238055f81da6 34 fields · synced May 30, 2026