Duns Number:607846297
Device Description: BEVC KIT BACTISEAL Endoscopic Ventricular Catheter and Distal Catheter Kit Includes: Ventr BEVC KIT BACTISEAL Endoscopic Ventricular Catheter and Distal Catheter Kit Includes: Ventricular Catheter 14cm (1), Distal Catheter 120cm (1), Right Angle Adaptor (1), Information manual (1)
Catalog Number
823088
Brand Name
BACTISEAL
Version/Model Number
82-3088
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 01, 2022
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K110751
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
4d88f20a-8d17-4f9e-b11f-f1848bcb9ec9
Public Version Date
September 01, 2022
Public Version Number
7
DI Record Publish Date
September 20, 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 | 40 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1054 |
| 3 | A medical device with high risk that requires premarket approval | 11 |