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 Fluid Management System Inflow Tubing (FMS DUO Plus or FMS Solo) FDA UDI
Model / Reference: 284504 FDA UDI
Description: FMS Fluid Management System Inflow Tubing (FMS DUO Plus or FMS Solo) FDA UDI

Identifiers

Catalog Number: 284504 FDA UDI
Primary DI / UDI-DI: 10886705017393 FDA UDI
510(k) Number: K951843 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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Cleared under the same submission

K951843 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 4cd18f67-30a1-4725-b4f8-9d354e833143 37 fields · synced Jun 8, 2026