Duns Number:080935429
Device Description: Quilted Adult Briefs, XL, Breathable, Heavy
Catalog Number
66135
Brand Name
Wings
Version/Model Number
66135
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
bc5c9803-d4e1-4bc6-91b3-ebaa132b81b7
Public Version Date
July 24, 2020
Public Version Number
1
DI Record Publish Date
July 16, 2020
Package DI Number
50885380177277
Quantity per Package
4
Contains DI Package
00885380177272
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 |