Catalog Number

-

Brand Name

CONMED

Version/Model Number

CD004

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

OCT

Product Code Name

Anti Fog Solution And Accessories, Endoscopy

Public Device Record Key

95bf2940-a42e-4794-8e77-3c68b16089ca

Public Version Date

February 17, 2020

Public Version Number

2

DI Record Publish Date

December 17, 2019

Package DI Number

24714127860897

Quantity per Package

10

Contains DI Package

14714127860890

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton