Duns Number:025460908
Device Description: BANDAGE,GAUZE,CURAD,ROLLED,3"X 4.1YD
Catalog Number
CUR47143RB
Brand Name
Curad
Version/Model Number
CUR47143RB
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
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
KGX
Product Code Name
Tape and bandage, adhesive
Public Device Record Key
3fbae339-d514-4c85-99cb-ac6ca8c2b6ba
Public Version Date
August 24, 2021
Public Version Number
2
DI Record Publish Date
January 20, 2021
Package DI Number
40080196302964
Quantity per Package
24
Contains DI Package
00080196302966
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 |