Duns Number:081325959
Device Description: Lumbar-Peritoneal Shunt Stainless Steel Connector
Catalog Number
NT75121S06
Brand Name
Natus®
Version/Model Number
NT75121S06
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"
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
K811288,K811288
Product Code
JXG
Product Code Name
Shunt, Central Nervous System And Components
Public Device Record Key
524ff1b0-391c-4581-baa2-2f175ef8abc7
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
April 17, 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 | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 302 |
| 3 | A medical device with high risk that requires premarket approval | 5 |