Monopolar scissors - UNIMAX MEDICAL SYSTEMS INC.

Duns Number:658122465

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More Product Details

Catalog Number

-

Brand Name

Monopolar scissors

Version/Model Number

FMS333050

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Device Record Status

Public Device Record Key

5bef7cbc-bf57-4663-b12c-03e6e548f578

Public Version Date

February 17, 2020

Public Version Number

5

DI Record Publish Date

September 18, 2017

Additional Identifiers

Package DI Number

24714127865984

Quantity per Package

100

Contains DI Package

14714127865987

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton

"UNIMAX MEDICAL SYSTEMS INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 67