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Variax

FDA UDI

Class II (US FDA UDI)

by Stryker Corp.

Identity

Trade Name
VARIAX FDA UDI
Generic Name
General external orthopaedic fixation system implantation kit, single-use FDA UDI
Device Name
DR Implant Kit, Interm Short RIGHT FDA UDI
Model / Reference
991060S FDA UDI
Description
DR Implant Kit, Interm Short RIGHT FDA UDI

Identifiers

Catalog Number
991060S FDA UDI
Primary DI / UDI-DI
07613327314625 FDA UDI
FDA Product Code
HWC FDA UDI
HRS FDA UDI
GMDN Term
General external orthopaedic fixation system implantation kit, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
888.3030 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

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

No

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 external orthopaedic fixation system implantation kit, single-use

Variax by Stryker Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General external orthopaedic fixation system implantation kit, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stryker Corp.

Sources (1)

  • FDA UDI 66a78596-8abf-487b-8b4f-7849f7bec3a8 34 fields · synced May 30, 2026