Fms

FDA UDI

Class II (US FDA UDI)

by DePuy Mitek, Inc.

Identity

Trade Name: FMS FDA UDI
Generic Name: Arthroscopic shaver system blade, single-use FDA UDI
Device Name: FMS Full Radius Cutter Shaver Blades 3.5mm FDA UDI
Model / Reference: 287305 FDA UDI
Description: FMS Full Radius Cutter Shaver Blades 3.5mm FDA UDI

Identifiers

Catalog Number: 287305 FDA UDI
Primary DI / UDI-DI: 10886705000333 FDA UDI
510(k) Number: K954465 FDA UDI
FDA Product Code: HRX FDA UDI
GMDN Term: Arthroscopic shaver system blade, single-use 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Arthroscopic shaver system blade, single-use

Fms by DePuy Mitek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Arthroscopic shaver system blade, single-use.

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SharkCut — Techcord co., Ltd · Class I

Cleared under the same submission

K954465 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: DePuy Mitek, Inc.

Sources (1)

FDA UDI 5f1886ea-f46c-41f1-94c3-6514b162213d 37 fields · synced Jun 8, 2026