Duns Number:081277700
Device Description: Ventricular Catheter with centimeter markings with BACTISEAL Shunt System. Contents: BACT Ventricular Catheter with centimeter markings with BACTISEAL Shunt System. Contents: BACTISEAL Ventricular Catheter (1), Stylet (1), RA Adapter (1), Information manual (1)
Catalog Number
NS5525
Brand Name
CODMAN® BACTISEAL®
Version/Model Number
NS5525
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K003322
Product Code
HCA
Product Code Name
CATHETER, VENTRICULAR
Public Device Record Key
69ee4f6f-3929-47f1-937f-23b47e04da2e
Public Version Date
October 25, 2022
Public Version Number
3
DI Record Publish Date
May 11, 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 | 15051 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4286 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 3 |