Catalog Number

FOAM-WHITE-A-16

Brand Name

Cork Medical

Version/Model Number

FOAM-WHITE-A-16

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

-

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

NAC

Product Code Name

Dressing, wound, hydrophilic

Public Device Record Key

a6049a7d-5065-4019-aa57-4c7ade6bfe53

Public Version Date

August 31, 2021

Public Version Number

1

DI Record Publish Date

August 23, 2021

Package DI Number

50749756933006

Quantity per Package

50

Contains DI Package

00749756933001

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case