Duns Number:531408342
Device Description: The Integra Flow Regulating Valves Low Flow (Standard, Mini) are implantable hydrocephalus
Catalog Number
909512
Brand Name
Integra Flow Regulating Valve Low Flow
Version/Model Number
909512
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K042192,K140722
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
8338a88b-df9f-4cbb-b08b-bc8961abe6a9
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
October 01, 2015
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 |