Catalog Number

8170-7

Brand Name

CONMED

Version/Model Number

8170-7

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 09, 2022

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

-

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

FET

Product Code Name

Endoscopic video imaging system/component, gastroenterology-urology

Public Device Record Key

1b0ea8d5-5784-4c41-ba7c-5faf05e5137c

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-