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Fms Omnicut

FDA UDI

Class II (US FDA UDI)

by Medos International Sàrl

Identity

Trade Name
FMS OMNICUT FDA UDI
Generic Name
Arthroscopic shaver system blade, single-use FDA UDI
Device Name
FMS OMNICUT Resection Blade 5.2mm SOFT TISSUE and BONE SHAVER BLADE FDA UDI
Model / Reference
283346 FDA UDI
Description
FMS OMNICUT Resection Blade 5.2mm SOFT TISSUE and BONE SHAVER BLADE FDA UDI

Identifiers

Catalog Number
283346 FDA UDI
Primary DI / UDI-DI
10886705022489 FDA UDI
510(k) Number
K130912 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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Arthroscopic shaver system blade, single-use

Fms Omnicut by Medos International Sàrl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K130912 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medos International Sàrl

Sources (1)

  • FDA UDI 4301f6af-7765-4f4f-9725-4d5eeafb80ce 36 fields · synced May 30, 2026