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Variax

FDA UDI

Class I (US FDA UDI)

by Stryker Corp.

Identity

Trade Name
VARIAX FDA UDI
Generic Name
Surgical implant template, reusable FDA UDI
Device Name
Plate Trial Elbow for Distal Medial Humerus FDA UDI
Model / Reference
703740 FDA UDI
Description
Plate Trial Elbow for Distal Medial Humerus FDA UDI

Identifiers

Catalog Number
703740 FDA UDI
Primary DI / UDI-DI
04546540681577 FDA UDI
FDA Product Code
HWT FDA UDI
GMDN Term
Surgical implant template, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4800 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 implant template, reusable

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

Similar devices

Also classified as Surgical implant template, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stryker Corp.

Sources (1)

  • FDA UDI 5c4661a6-cbf1-420f-a75c-b697c9d40b69 35 fields · synced Jun 8, 2026