Catalog Number

-

Brand Name

FreeDerm

Version/Model Number

52203

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 02, 2022

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

9497a06b-670e-4036-b8a8-4b1d7f7b920e

Public Version Date

February 18, 2022

Public Version Number

2

DI Record Publish Date

February 06, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-