Identity
- Trade Name
- Multi System FDA UDI
- Generic Name
- Orthopaedic chisel FDA UDI
- Device Name
- Bone Fenestration Chisel, Curved FDA UDI
- Model / Reference
- P99-150-0135 FDA UDI
- Description
- Bone Fenestration Chisel, Curved FDA UDI
Identifiers
- Catalog Number
- P99-150-0135 FDA UDI
- Primary DI / UDI-DI
- 00889795054364 FDA UDI
- FDA Product Code
- HTF FDA UDI
- GMDN Term
- Orthopaedic chisel 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
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
Yes
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
MR Unsafe FDA UDI
Category: Orthopaedic chisel
Multi System by Paragon 28 — 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
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- 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 |
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Manufacturer
- Manufacturer
- Paragon 28
Sources (1)
- FDA UDI b8ca9823-4559-4335-a98d-f1a11a3cebbb 34 fields · synced May 30, 2026