Duns Number:531408342
Device Description: The Radiopaque Polypropylene Plug consists of a Tubing Plug provided for surgeons using th The Radiopaque Polypropylene Plug consists of a Tubing Plug provided for surgeons using the Integral Ventricular Reservoir (IVR) who prefer to use the wire introducer for introduction of the ventricular catheter. The plug allows to close the catheter after its placement.
Catalog Number
9MZ500
Brand Name
Radiopaque Polypropylene Plug
Version/Model Number
9MZ500
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
Yes
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
K955832
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
db81d05c-c054-4c2f-8ef0-e9696a9fa066
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
October 01, 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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 197 |