Duns Number:315892968
Device Description: Cosmea Comfort pantyliners normal with Aloe Vera
Catalog Number
-
Brand Name
Cosmea
Version/Model Number
normal
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"
-
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
HHL
Product Code Name
Pad, Menstrual, Scented
Public Device Record Key
89e79910-880e-4512-9d82-35d0d1970552
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
September 14, 2020
Package DI Number
04000576022969
Quantity per Package
58
Contains DI Package
04000576042103
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
sales package
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |