Duns Number:961027315
Device Description: PAD THIN NONWOVEN TOP SUPER ABSORBENCY OVERNIGHT UNSCENTED NON-STERILE
Catalog Number
FH-PADOB
Brand Name
CARDINAL HEALTH
Version/Model Number
FH-PADOB
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2021
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
HHD
Product Code Name
Pad, menstrual, unscented
Public Device Record Key
9f663899-49a5-4072-88c4-1ea4baa60e50
Public Version Date
December 31, 2021
Public Version Number
3
DI Record Publish Date
June 06, 2019
Package DI Number
10888499000681
Quantity per Package
12
Contains DI Package
00888499000684
Package Discontinue Date
December 31, 2021
Package Status
Not 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 |