Duns Number:531408342
Device Description: Connectors are implantable accessories intended to be used with Integra Hydrocephalus Valv
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 |