Catalog Number

SC11A3

Brand Name

Endure

Version/Model Number

SC11A3-0520

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

KGX

Product Code Name

Tape And Bandage, Adhesive

Public Device Record Key

bf8eec03-04ce-4003-9495-44552d73b890

Public Version Date

October 07, 2020

Public Version Number

1

DI Record Publish Date

September 29, 2020

Package DI Number

00840118605038

Quantity per Package

24

Contains DI Package

00840118600750

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case