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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
450078CT12 FDA UDI
Description
General Surgery Tray FDA UDI

Identifiers

Primary DI / UDI-DI
10885632040047 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

SurgiTrack by Owens & Minor Distribution, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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 15ee2583-ddde-4c66-8dbc-547417e266c5 33 fields · synced Jun 8, 2026