Video Processor - Digital Processing Unit - Reconditioned - COGENTIX MEDICAL, INC.

Duns Number:780024725

Device Description: Digital Processing Unit - Reconditioned

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More Product Details

Catalog Number

07-5051P

Brand Name

Video Processor

Version/Model Number

DPU-5050A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 23, 2016

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

eb9f852f-1cbd-4000-bc1a-3a1075cc9bea

Public Version Date

May 19, 2020

Public Version Number

6

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