CONMED CLEARGUARD - CONMED CLEARGUARD BIOPSY VALVES, DISPOSABLE - Conmed Corporation

Duns Number:071595540

Device Description: CONMED CLEARGUARD BIOPSY VALVES, DISPOSABLE BIOPSY VALVE FOR PENTAX GI ENDOSCOPES

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More Product Details

Catalog Number

00523B

Brand Name

CONMED CLEARGUARD

Version/Model Number

00523B

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 29, 2021

Issuing Agency

In GS1

Product Characteristics

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

K090851,K090851,K090851

Product Code Details

Product Code

ODC

Product Code Name

Endoscope channel accessory

Device Record Status

Public Device Record Key

3d68c9f7-dc81-463f-87ed-957887863f70

Public Version Date

July 01, 2021

Public Version Number

4

DI Record Publish Date

September 15, 2017

Additional Identifiers

Package DI Number

10653405063254

Quantity per Package

400

Contains DI Package

20653405063251

Package Discontinue Date

October 21, 2020

Package Status

Not in Commercial Distribution

Package Type

CASE

"CONMED CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1412
2 A medical device with a moderate to high risk that requires special controls. 2261
3 A medical device with high risk that requires premarket approval 95