Duns Number:801160037
Device Description: : NovaGel is indicated for use as a scar management dressing on old and new hypertrophic : NovaGel is indicated for use as a scar management dressing on old and new hypertrophic or keloid scars.
Catalog Number
GEL-6505
Brand Name
Nova Gel
Version/Model Number
GEL-6505
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"
-
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
MDA
Product Code Name
Elastomer, Silicone, For Scar Management
Public Device Record Key
6f6a80ba-d5f6-49ca-a416-43d2fa7baaed
Public Version Date
October 30, 2020
Public Version Number
1
DI Record Publish Date
October 22, 2020
Package DI Number
00855638007132
Quantity per Package
5
Contains DI Package
00855638007125
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |
| U | Unclassified | 3 |