Catalog Number

1061

Brand Name

Sea-Clens

Version/Model Number

1061

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

-

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

NEC

Product Code Name

Bandage, liquid, skin protectant

Public Device Record Key

5c143ab6-7e82-46af-b2e2-bbc4d6ac53de

Public Version Date

May 02, 2022

Public Version Number

1

DI Record Publish Date

April 22, 2022

Package DI Number

00311701159554

Quantity per Package

1

Contains DI Package

00311701159356

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper Box