Duns Number:961027315
Device Description: Women's Protective Underwear, Sure Care
Catalog Number
UWFLG18
Brand Name
CARDINAL HEALTH
Version/Model Number
UWFLG18
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
EYQ
Product Code Name
GARMENT, PROTECTIVE, FOR INCONTINENCE
Public Device Record Key
54f31c06-5322-4eef-a345-4d338e0fa74b
Public Version Date
February 21, 2022
Public Version Number
2
DI Record Publish Date
February 01, 2022
Package DI Number
50192253014479
Quantity per Package
4
Contains DI Package
00192253014474
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 | 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 |