Catalog Number

-

Brand Name

CONMED CleanGuide

Version/Model Number

CG-10-1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KNQ

Product Code Name

Dilator, Esophageal

Public Device Record Key

d7b37759-df60-4a1f-b7d8-aa5c7bc4f3d1

Public Version Date

August 27, 2021

Public Version Number

2

DI Record Publish Date

April 12, 2021

Package DI Number

16971890564587

Quantity per Package

3

Contains DI Package

06971890564580

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Box