Duns Number:482661753
Device Description: CODMAN CERTAS SIPHONGUARD Plus Programmable Valve Inline Small Valve with SIPHONGUARD, Acc CODMAN CERTAS SIPHONGUARD Plus Programmable Valve Inline Small Valve with SIPHONGUARD, Accessories and Unitized Catheter Includes: Ventricular Catheter, Unitized Distal Catheter, Priming Adapter, Right Angle Adapter and Information Manual
Catalog Number
828816PL
Brand Name
CODMAN CERTAS SIPHONGUARD
Version/Model Number
82-8816PL
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 01, 2022
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
-
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
eae45c6f-9a94-4fd0-b59e-ea99a3c2c5e7
Public Version Date
September 01, 2022
Public Version Number
5
DI Record Publish Date
January 21, 2019
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 | 972 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6382 |
| 3 | A medical device with high risk that requires premarket approval | 20 |
| U | Unclassified | 20 |