Duns Number:315304071
Device Description: FIBER-CYSTOSCOPE 15FR WL 400MM flexible, working channel 7.5Fr, slanted distal tip, TL 66 FIBER-CYSTOSCOPE 15FR WL 400MM flexible, working channel 7.5Fr, slanted distal tip, TL 660mm, deflection +210°/-150°, glass fiber light cable, fiber image carrier, manual focus
Catalog Number
7305.006
Brand Name
NA
Version/Model Number
7305006
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FAJ
Product Code Name
Cystoscope and accessories, flexible/rigid
Public Device Record Key
2689aa90-accd-43ff-ab82-4176bb2d7d08
Public Version Date
April 26, 2021
Public Version Number
3
DI Record Publish Date
September 23, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 587 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1835 |