Duns Number:262951353
Device Description: CRx Universal Shunt, 11 cm ventricular catheter, Low Pressure
Catalog Number
-
Brand Name
Phoenix Neuro
Version/Model Number
CRX140U
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K024101
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
b5150475-333f-4c27-a03b-b4eb93cd667b
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
October 16, 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 223 |