Duns Number:959181160
Device Description: Smart Flow Neuro Ventricular Cannula, 16ga, .008 ID x 10 ft x 13mm tip
Catalog Number
NGS-NC-06
Brand Name
SmartFlow
Version/Model Number
NGS-NC-06
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)
Yes
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
K102101
Product Code
HCD
Product Code Name
Cannula, Ventricular
Public Device Record Key
e02f0e90-b975-4952-ad10-f8152b14ee00
Public Version Date
June 22, 2022
Public Version Number
4
DI Record Publish Date
January 22, 2021
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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 138 |