Catalog Number

-

Brand Name

FreeDerm

Version/Model Number

52200

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

c1b4c30a-5928-4b68-bc64-4f09e63cdffb

Public Version Date

March 31, 2020

Public Version Number

1

DI Record Publish Date

March 23, 2020

Package DI Number

00653599001097

Quantity per Package

36

Contains DI Package

00653599000045

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box