Catalog Number

20-350

Brand Name

FOXSEAL - CMS

Version/Model Number

FG05814491

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

NAD

Product Code Name

Dressing, Wound, Occlusive

Public Device Record Key

8464448d-fbf7-4968-af23-fb05d098f2f5

Public Version Date

April 08, 2021

Public Version Number

1

DI Record Publish Date

March 31, 2021

Package DI Number

75060206630702

Quantity per Package

100

Contains DI Package

15060206630700

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper