Duns Number:961027315
Device Description: NOVAPLUS CAP SURGEON EASY TIE
Catalog Number
V4359
Brand Name
CARDINAL HEALTH
Version/Model Number
V4359
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
November 13, 2023
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FYF
Product Code Name
CAP, SURGICAL
Public Device Record Key
05133d79-bf03-46da-8305-94981c7a7312
Public Version Date
December 22, 2021
Public Version Number
3
DI Record Publish Date
November 14, 2018
Package DI Number
50885380114722
Quantity per Package
6
Contains DI Package
20885380114721
Package Discontinue Date
November 12, 2023
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |