Identity
- Trade Name
- Pomee FDA UDI
- Generic Name
- Orthopaedic chisel FDA UDI
- Device Name
- Bone Chisels Wakefield # 2W double bevel FDA UDI
- Model / Reference
- 702-375 FDA UDI
- Description
- Bone Chisels Wakefield # 2W double bevel FDA UDI
Identifiers
- Catalog Number
- 702-375 FDA UDI
- Primary DI / UDI-DI
- G1577023750 FDA UDI
- FDA Product Code
- EML FDA UDI
- GMDN Term
- Orthopaedic chisel FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic chisel
Pomee by Pomee Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic chisel.
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- Gimmi — Gimmi GmbH · Class I
- CHISEL — KLS-Martin L.P. · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- gSource — GSOURCE, LLC. · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- Novo Surgical — NOVO SURGICAL, 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
- Pomee Corporation
Sources (1)
- FDA UDI 1f56ebaa-c805-413c-a36c-79b3aaee85fb 34 fields · synced Jun 8, 2026