Duns Number:010741028
Device Description: 4.0 mm, 30 deg. Cystoscope, l=302mm, autoclavable ( Cysto sheath ONLY-NOT Resectoscope/Wor 4.0 mm, 30 deg. Cystoscope, l=302mm, autoclavable ( Cysto sheath ONLY-NOT Resectoscope/Working Element )
Catalog Number
30-0057-00
Brand Name
IEC-Innoview GmbH
Version/Model Number
30-0057-00
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K992983
Product Code
FAJ
Product Code Name
Cystoscope And Accessories, Flexible/Rigid
Public Device Record Key
8efdbfea-2813-4faa-b1af-13b7b5457cae
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 24, 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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 24 |