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Formula

FDA UDI

Class I (US FDA UDI)

by Stryker Corp.

Identity

Trade Name
Formula FDA UDI
Generic Name
Arthroscopic shaver system, electrically-powered FDA UDI
Device Name
XL Tomcat, Hip Cutter. Arthroscopic Shaver Blade. For use with: REF 0375-701-500, 0375-704-500, 0375-708-500. Do Not Use if Package is Damaged, Keep Dry, Keep Away from Sunlight FDA UDI
Model / Reference
0385545000 FDA UDI
Description
XL Tomcat, Hip Cutter. Arthroscopic Shaver Blade. For use with: REF 0375-701-500, 0375-704-500, 0375-708-500. Do Not Use if Package is Damaged, Keep Dry, Keep Away from Sunlight FDA UDI

Identifiers

Catalog Number
0385-545-000 FDA UDI
Primary DI / UDI-DI
07613327055139 FDA UDI
FDA Product Code
GFA FDA UDI
GMDN Term
Arthroscopic shaver system, electrically-powered FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4820 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

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 180.0 Millimeter FDA UDI
Outer Diameter — 4.0 Millimeter FDA UDI

Category: Arthroscopic shaver system, electrically-powered

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

Similar devices

Also classified as Arthroscopic shaver system, electrically-powered.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stryker Corp.

Sources (1)

  • FDA UDI ce33925b-3c88-41ef-9fab-73f98d984f30 36 fields · synced Jun 8, 2026