Identity
- Trade Name
- Trauma Fixation Systems FDA UDI
- Generic Name
- Manual wire driver FDA UDI
- Model / Reference
- 27913 FDA UDI
Identifiers
- Catalog Number
- 27913 FDA UDI
- Primary DI / UDI-DI
- 00887868472008 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Manual wire driver 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
Category: Manual wire driver
Trauma Fixation Systems by Biomet Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Manual wire driver.
- PIN DRIVER — SONTEC INSTRUMENTS, INC. · Class I
- PRECICE® Intramedullary Limb Lengthening System Instrument — NuVasive Specialized Orthopedics, Inc. · Class I
- gSource — GSOURCE, LLC. · Class I
- gSource — GSOURCE, LLC. · Class I
- PRECICE® Trauma Nail System — NuVasive Specialized Orthopedics, Inc. · Class I
- VICKERS EASY DRIVER — SONTEC INSTRUMENTS, INC. · Class I
- OPTY-LINE — NuVasive Specialized Orthopedics, Inc. · Class I
- KMEDIC — TELEFLEX INCORPORATED · 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
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI 08b008c8-c1a0-43be-8360-88587ce956a8 34 fields · synced Jun 6, 2026