Duns Number:188684609
Device Description: Neo-Nephroscope 12 FR Rigid with 5.0 working channel
Catalog Number
NNC12
Brand Name
Prosurg
Version/Model Number
NNC12
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
-
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
K120766,K120766
Product Code
FAJ
Product Code Name
Cystoscope And Accessories, Flexible/Rigid
Public Device Record Key
bb468726-72c3-423b-b5fe-2e86dfbfae81
Public Version Date
May 08, 2020
Public Version Number
1
DI Record Publish Date
April 30, 2020
Package DI Number
10851545007651
Quantity per Package
1
Contains DI Package
00851545007654
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Pak
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 79 |