Catalog Number

4963, 4975

Brand Name

OPSITE INCISE 14X10CM CTN 10 or CTN 50

Version/Model Number

4963, 4975

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

01c2babc-01e6-4705-89fe-c2992f4c833e

Public Version Date

December 22, 2021

Public Version Number

3

DI Record Publish Date

September 18, 2020

Package DI Number

05000223049638

Quantity per Package

10

Contains DI Package

05000223415464

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton 4963