Catalog Number

-

Brand Name

FreeDerm

Version/Model Number

90037

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KOX

Product Code Name

Solvent, Adhesive Tape

Public Device Record Key

fb478a72-7be6-45f6-93f5-f713ee6ac2d9

Public Version Date

December 09, 2020

Public Version Number

2

DI Record Publish Date

April 14, 2020

Package DI Number

10653599000646

Quantity per Package

30

Contains DI Package

00653599000649

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box