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TraumaOne SYSTEM

FDA UDI

Class I (US FDA UDI)

by Biomet Microfixation, Inc

Identity

Trade Name
TraumaOne SYSTEM FDA UDI
Generic Name
Surgical instrument/implant rack FDA UDI
Model / Reference
46-1502-18 FDA UDI

Identifiers

Catalog Number
46-1502-18 FDA UDI
Primary DI / UDI-DI
00841036284633 FDA UDI
FDA Product Code
LRP FDA UDI
GMDN Term
Surgical instrument/implant rack 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Surgical instrument/implant rack

The TraumaOne SYSTEM is a cutting-edge, reusable surgical instrument rack designed to provide a secure and organized storage solution for general plastic surgery procedures. With its innovative design and high-quality materials, this device is ideal for surgeons and medical professionals who require a reliable and efficient way to manage their surgical instruments and implants.

Similar devices

Also classified as Surgical instrument/implant rack.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomet Microfixation, Inc

Sources (1)

  • FDA UDI 21575706-0f5a-42fa-bd47-a93411ca667d 34 fields · synced Jul 12, 2026