Duns Number:188684609
Device Description: NEO-CYSTOSCOPE , DIAGNOSTIC SHEATH
Catalog Number
-
Brand Name
Neoscope
Version/Model Number
NDS 35
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
c6f431e3-bb1b-4fff-922a-be90c8c7eb85
Public Version Date
April 22, 2020
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
10851545007477
Quantity per Package
1
Contains DI Package
00851545007470
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 79 |