Catalog Number

FG08814441

Brand Name

Foxseal

Version/Model Number

FG08814441

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)

Yes

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

c87b08b7-37dd-43db-8b91-66b921ccb404

Public Version Date

July 08, 2020

Public Version Number

1

DI Record Publish Date

June 30, 2020

Package DI Number

75060206630634

Quantity per Package

100

Contains DI Package

15060206630632

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Case