Duns Number:780024725
Device Description: Digital Processing Unit with Integrated LCD Display and Air Insufflation
Catalog Number
07-5051
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
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
FAJ
Product Code Name
Cystoscope And Accessories, Flexible/Rigid
Public Device Record Key
0478d4e7-38e3-4d96-b244-a0f3281b7dcf
Public Version Date
May 19, 2020
Public Version Number
6
DI Record Publish Date
September 22, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 33 |