Duns Number:025460908
Device Description: DBD-CURAD,TAPE,TRANSPARENT,1X10YDS,2PK,2
Catalog Number
CUR262012
Brand Name
Curad
Version/Model Number
CUR262012
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
KGX
Product Code Name
Tape and bandage, adhesive
Public Device Record Key
af68ecfb-d001-4e15-9aa6-bf8307657fa6
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
February 04, 2022
Package DI Number
40884389162256
Quantity per Package
24
Contains DI Package
30884389162259
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
RETAIL OUTER PACK
| 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 |