Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

8101

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K030339,K030339,K030339

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

814fce6d-3f24-49dd-b01d-26b363a8292b

Public Version Date

October 21, 2020

Public Version Number

4

DI Record Publish Date

August 20, 2016

Package DI Number

20809160003210

Quantity per Package

25

Contains DI Package

10809160003213

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-