Catalog Number

-

Brand Name

Medical Action Industries

Version/Model Number

425S

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

K102158,K102158

Product Code

FRG

Product Code Name

Wrap, sterilization

Public Device Record Key

1cf5a2d0-4720-4d79-b958-d9e9fddf33a9

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

August 20, 2016

Package DI Number

20809160005276

Quantity per Package

4

Contains DI Package

10809160005279

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-