Catalog Number

4542

Brand Name

OPSITE 28X10CM US CTN 10

Version/Model Number

4542

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)

-

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

26c10419-7200-4b74-9cda-050503a5a03f

Public Version Date

December 22, 2021

Public Version Number

4

DI Record Publish Date

May 15, 2020

Package DI Number

05000223403799

Quantity per Package

10

Contains DI Package

05000223415396

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton