Catalog Number

-

Brand Name

Mepiform®

Version/Model Number

293288

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

MDA

Product Code Name

Elastomer, silicone, for scar management

Public Device Record Key

2f96a568-e766-4459-9516-b9661a8040fa

Public Version Date

August 05, 2020

Public Version Number

1

DI Record Publish Date

July 28, 2020

Package DI Number

07323190105229

Quantity per Package

5

Contains DI Package

00050428305072

Package Discontinue Date

December 31, 1995

Package Status

Not in Commercial Distribution

Package Type

-