Catalog Number

FG08814541

Brand Name

FOXSEAL Vented

Version/Model Number

FG08814541

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)

Yes

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

c69afc0a-2808-4af3-9d25-521a7dcf580f

Public Version Date

February 14, 2022

Public Version Number

1

DI Record Publish Date

February 04, 2022

Package DI Number

75060206630696

Quantity per Package

100

Contains DI Package

15060206630694

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Case