Catalog Number

802500000

Brand Name

Skin Fix

Version/Model Number

802500000

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

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

KGZ

Product Code Name

Accessories, Catheter

Public Device Record Key

2ea1e0fa-5b2f-4bc4-a79a-076a462a38a1

Public Version Date

July 22, 2022

Public Version Number

1

DI Record Publish Date

July 14, 2022

Package DI Number

20886333001402

Quantity per Package

25

Contains DI Package

00886333001408

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box