Catalog Number

9642

Brand Name

Dermacea

Version/Model Number

9642

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

-

Product Code

KGX

Product Code Name

Tape and bandage, adhesive

Public Device Record Key

61a5a32e-b798-419c-b155-85b7c94f7e56

Public Version Date

June 19, 2020

Public Version Number

3

DI Record Publish Date

June 27, 2018

Package DI Number

30884527022568

Quantity per Package

2400

Contains DI Package

10884527022564

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE