Flexible Video Cystoscope (NTSC) Intuitive Reconditioned - Intuitive Reconditioned - COGENTIX MEDICAL, INC.

Duns Number:780024725

Device Description: Intuitive Reconditioned

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More Product Details

Catalog Number

08-5203P

Brand Name

Flexible Video Cystoscope (NTSC) Intuitive Reconditioned

Version/Model Number

CST-5000i

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K072180

Product Code Details

Product Code

FAJ

Product Code Name

Cystoscope And Accessories, Flexible/Rigid

Device Record Status

Public Device Record Key

c8d98679-4f6f-4007-9ca2-d1330251bf3c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

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