Duns Number:080935429
Device Description: Cardinal Health Quilted Adult Briefs Wings Super
Catalog Number
87085
Brand Name
Covidien
Version/Model Number
87085
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
EYQ
Product Code Name
GARMENT, PROTECTIVE, FOR INCONTINENCE
Public Device Record Key
092a7d32-9ab3-4a2b-8278-915dd861ab46
Public Version Date
June 19, 2020
Public Version Number
1
DI Record Publish Date
June 11, 2020
Package DI Number
50192253022887
Quantity per Package
4
Contains DI Package
00192253022882
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 | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |