Duns Number:961027315
Device Description: Cardinal Health; Maxi Pad; Contoured
Catalog Number
FH-PADPCH
Brand Name
CARDINAL HEALTH
Version/Model Number
FH-PADPCH
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
December 31, 2022
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
HHD
Product Code Name
Pad, menstrual, unscented
Public Device Record Key
b6d4cf35-f5de-42ac-bdea-b2113c50d2f9
Public Version Date
April 12, 2021
Public Version Number
3
DI Record Publish Date
December 02, 2018
Package DI Number
50885380049093
Quantity per Package
9
Contains DI Package
70885380049097
Package Discontinue Date
December 31, 2022
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |