Catalog Number

4986

Brand Name

OPSITE INCISE 15X28CM CTN 10

Version/Model Number

4986

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

730a0004-54cf-44e7-9c16-a733f97dab58

Public Version Date

December 22, 2021

Public Version Number

3

DI Record Publish Date

September 18, 2020

Package DI Number

05000223049867

Quantity per Package

10

Contains DI Package

05000223415495

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton