Duns Number:531408342
Device Description: Contour-Flex Valve System, Regular, Medium Pressure for ventricular shunting of cerebrospi Contour-Flex Valve System, Regular, Medium Pressure for ventricular shunting of cerebrospinal fluid.
Catalog Number
12509
Brand Name
Contour-Flex Valve and Shunt System
Version/Model Number
12509
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 30, 2021
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
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
-
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
78842cf4-1ea0-4b5b-9f3a-5e4fbfff9733
Public Version Date
June 30, 2021
Public Version Number
6
DI Record Publish Date
January 12, 2018
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 197 |