Duns Number:025460908
Device Description: DBD-BANDAGE,PRESSURE,CUR,1"X3",20CT,24BX
Catalog Number
CUR440189
Brand Name
Curad
Version/Model Number
CUR440189
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
06e00ae0-247f-4315-8648-b5eff0dedc9a
Public Version Date
March 14, 2022
Public Version Number
1
DI Record Publish Date
March 04, 2022
Package DI Number
40884389155197
Quantity per Package
24
Contains DI Package
30884389155190
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 |