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Fms

FDA UDI

Class II (US FDA UDI)

by DePuy Mitek, Inc.

Identity

Trade Name
FMS FDA UDI
Generic Name
Arthroscopic shaver system, electrically-powered FDA UDI
Device Name
FMS Tornado Shaver Handpiece 8000 RPM FDA UDI
Model / Reference
288022 FDA UDI
Description
FMS Tornado Shaver Handpiece 8000 RPM FDA UDI

Identifiers

Catalog Number
288022 FDA UDI
Primary DI / UDI-DI
10886705018345 FDA UDI
FDA Product Code
HRX FDA UDI
GMDN Term
Arthroscopic shaver system, electrically-powered FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.1100 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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Arthroscopic shaver system, electrically-powered

Fms by DePuy Mitek, Inc. — Class II — 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
DePuy Mitek, Inc.

Sources (1)

  • FDA UDI 78146fe4-2918-4cb7-b3e8-004c01703f88 36 fields · synced Jun 8, 2026