Duns Number:025460908
Device Description: DBD-BNDG,SOOTHE&COOL,CURAD,OVAL,4X4.75",
Catalog Number
CUR5239
Brand Name
Curad
Version/Model Number
CUR5239
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
NAE
Product Code Name
Dressing, wound, hydrogel without drug and/or biologic
Public Device Record Key
43e58ec7-e0cc-4e2a-8f5b-20177fe3323d
Public Version Date
April 18, 2022
Public Version Number
1
DI Record Publish Date
April 08, 2022
Package DI Number
30888277363216
Quantity per Package
3
Contains DI Package
00888277363215
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
RETAIL INNER 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 |