Duns Number:080935429
Device Description: Adult Bariatric Briefs,Extra Heavy
Catalog Number
67095
Brand Name
Wings
Version/Model Number
67095
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
-
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
8514cf09-fb78-43de-808b-1372149c2a7c
Public Version Date
February 15, 2019
Public Version Number
2
DI Record Publish Date
June 27, 2018
Package DI Number
10884521161085
Quantity per Package
32
Contains DI Package
20884521544489
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACK_OR_INNER_PACK
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 |