Duns Number:092364462
Catalog Number
-
Brand Name
NOVAPLUS
Version/Model Number
78810
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 15, 2019
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OVN
Product Code Name
Suture kit
Public Device Record Key
f5d17569-0506-4b54-88ba-f9169248a1b3
Public Version Date
May 16, 2019
Public Version Number
2
DI Record Publish Date
August 15, 2018
Package DI Number
20809160205638
Quantity per Package
20
Contains DI Package
10809160205631
Package Discontinue Date
May 15, 2019
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 548 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2798 |
| U | Unclassified | 1 |