Duns Number:025460908
Device Description: COLD PACK,INSTANT,CURAD,2/BX,24CS
Catalog Number
CUR961R
Brand Name
Curad
Version/Model Number
CUR961R
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
IMD
Product Code Name
PACK, HOT OR COLD, DISPOSABLE
Public Device Record Key
95cdd2ab-2213-4ea3-8eec-ab9acdd3cd37
Public Version Date
May 24, 2021
Public Version Number
1
DI Record Publish Date
May 14, 2021
Package DI Number
40080196493075
Quantity per Package
4
Contains DI Package
40080196282167
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| 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 |