Duns Number:480186617
Device Description: Programmable Valve Right Angle Valve with SIPHONGUARD, Accessories and UnitizedCatheter In Programmable Valve Right Angle Valve with SIPHONGUARD, Accessories and UnitizedCatheter Includes:Ventricular Catheter,Unitized Distal Catheter, Priming Adapter and Information Manual
Catalog Number
82-8827PL
Brand Name
CODMAN CERTAS® SIPHONGUARD® BACTISEAL®
Version/Model Number
828827PL
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"
-
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
K182265
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
164b8bb7-1ae1-4309-b2df-ee2adf3ebdd0
Public Version Date
September 22, 2021
Public Version Number
3
DI Record Publish Date
June 02, 2020
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 69 |