Duns Number:083171244
Device Description: The Infant Cardiac Catheter model is designed for ventriculoatrial shunting of CSF in chil The Infant Cardiac Catheter model is designed for ventriculoatrial shunting of CSF in children with small veins. The distal section of the catheter is reduced to approximately one-half standard diameter for easier insertion. The proximal section of the catheter contains an imbedded barium sulfate-impregnated strip, and the distal section is fully barium sulfate-impregnated. The infant model does not contain graduation markets.
Catalog Number
NL8501221
Brand Name
Integra Pudenz Infant Cardiac Catheter
Version/Model Number
NL8501221
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
35c5c998-b1d0-46fb-85e0-2e0cec29187c
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
December 15, 2016
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 | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 75 |
| 3 | A medical device with high risk that requires premarket approval | 17 |
| U | Unclassified | 32 |