EndoSheath Technology - EndoSheath Technology for CST-4000 Cystoscope - COGENTIX MEDICAL, INC.

Duns Number:780024725

Device Description: EndoSheath Technology for CST-4000 Cystoscope

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More Product Details

Catalog Number

08-4102

Brand Name

EndoSheath Technology

Version/Model Number

CF-1.5

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

Yes

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

K071127,K071127

Product Code Details

Product Code

HIH

Product Code Name

Hysteroscope (And Accessories)

Device Record Status

Public Device Record Key

5e4c52c6-abd8-4d67-a6ae-56761b867e99

Public Version Date

November 10, 2021

Public Version Number

6

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

20874485001302

Quantity per Package

10

Contains DI Package

00874485003159

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"COGENTIX MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 33