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

FMS333057

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

e21cd0f6-72e4-4ce6-850b-ddfaf343a31e

Public Version Date

February 17, 2020

Public Version Number

3

DI Record Publish Date

January 22, 2019

Additional Identifiers

Package DI Number

24714127868466

Quantity per Package

100

Contains DI Package

14714127868469

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