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

FMS445055

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

ecbb35cd-0e28-4160-86a6-9e369c6057eb

Public Version Date

February 17, 2020

Public Version Number

5

DI Record Publish Date

February 06, 2018

Additional Identifiers

Package DI Number

14714127862986

Quantity per Package

10

Contains DI Package

04714127862989

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box

"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