Duns Number:025460908
Device Description: DBD-SCAR,ADVGEL THERAPYCURAD,1X3"STRIP,6
Catalog Number
CUR0023
Brand Name
Curad
Version/Model Number
CUR0023
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
-
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
0d98b06d-2567-4eaa-9b3e-3240926e6e16
Public Version Date
August 12, 2022
Public Version Number
1
DI Record Publish Date
August 04, 2022
Package DI Number
30884389124318
Quantity per Package
6
Contains DI Package
00884389124317
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CARTON
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |