Duns Number:089055867
Device Description: SHUNT 24133-2 CSF-DELTA CHMBR PERIT 2.0
Catalog Number
-
Brand Name
NA
Version/Model Number
24133-2
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K873247
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
2200a358-52ba-4e19-880f-54af13f989ab
Public Version Date
October 10, 2022
Public Version Number
4
DI Record Publish Date
June 17, 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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1465 |