Duns Number:531408342
Device Description: Connectors are implantable accessories intended to be used with Integra Hydrocephalus Valv Connectors are implantable accessories intended to be used with Integra Hydrocephalus Valve Systems for connection between an implanted ventricular catheter or drainage catheter and a CSF Shunt System.
Catalog Number
901412
Brand Name
Stainless Steel Connector
Version/Model Number
901412
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
K152897,K861377,K152897,K861377
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
d4377062-86e1-4c64-9ae3-739fdd2fa100
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
October 01, 2015
Package DI Number
30381780033367
Quantity per Package
5
Contains DI Package
10381780033363
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |