Catalog Number

-

Brand Name

Cerdak

Version/Model Number

Cerdak Aerofilm

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K153138,K153138,K153138

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Public Device Record Key

b24c6b75-8e28-44c9-bdc9-58770701cfa6

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

January 18, 2018

Package DI Number

18903389005286

Quantity per Package

10

Contains DI Package

58903389005284

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-