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SurgiTrack

FDA UDI

Class II (US FDA UDI)

by Owens & Minor Distribution, Inc.

Identity

Trade Name
SurgiTrack FDA UDI
Generic Name
General surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
General Surgery Tray FDA UDI
Model / Reference
450037FU17 FDA UDI
Description
General Surgery Tray FDA UDI

Identifiers

Primary DI / UDI-DI
10885632005022 FDA UDI
FDA Product Code
LRO FDA UDI
GMDN Term
General surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4370 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: General surgical procedure kit, non-medicated, single-use

A comprehensive collection of surgical instruments, often used during general surgery procedures such as open abdominal surgery, minor dermatological surgery, or cosmetic surgery below the head.

Similar devices

Also classified as General surgical procedure kit, non-medicated, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Owens & Minor Distribution, Inc.

Sources (1)

  • FDA UDI b9a75ac7-bdf5-4fcc-a4b9-4f4e2788e67f 33 fields · synced Jul 21, 2026