Identity
- Trade Name
- Multi System FDA UDI
- Generic Name
- Bone distraction forceps FDA UDI
- Device Name
- Large Ankle Tenaculum FDA UDI
- Model / Reference
- P99-150-0038 FDA UDI
- Description
- Large Ankle Tenaculum FDA UDI
Identifiers
- Catalog Number
- P99-150-0038 FDA UDI
- Primary DI / UDI-DI
- 00889795040916 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Bone distraction forceps 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
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: Bone distraction forceps
Multi System by Paragon 28 — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone distraction forceps.
- SMITH SAGGITAL SPLITTER-MOD — W.H. Holden, Inc. · Class I
- Arsenal Foot — Trilliant Surgical LLC · Class I
- Cortera — Xtant Medical Holdings, Inc. · Class I
- Arsenal Ankle — Trilliant Surgical LLC · Class I
- BITE COMPRESSION SCREWS — Orthofix, Inc. · Class II
- “Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile) — Paonan Biotech Co., Ltd. · Class I
- KMEDIC — TELEFLEX INCORPORATED · Class I
- Invictus — ALPHATEC SPINE, 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
- Paragon 28
Sources (1)
- FDA UDI 99e70fc3-1a5b-4050-9be0-6a5f3fb58b19 34 fields · synced May 31, 2026