Duns Number:482661753
Device Description: CODMAN CERTAS BACTISEAL Plus Programmable Valve Right Angle Valve with Accessories and Uni CODMAN CERTAS BACTISEAL Plus Programmable Valve Right Angle Valve with Accessories and Unitized BACTISEAL Catheter Includes: BACTISEAL Ventricular Catheter, BACTISEAL Unitized Distal Catheter, Priming Adapter and Information Manual
Catalog Number
828823PL
Brand Name
CODMAN CERTAS BACTISEAL
Version/Model Number
82-8823PL
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
27c2d56a-8170-4c6c-9008-825480467cf2
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 |