Duns Number:078740398
Device Description: Abena Essentials washable Underpads that measures 35" x 42".
Catalog Number
-
Brand Name
Abena
Version/Model Number
2593
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
January 01, 2023
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)
-
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
86adf9ba-4342-45ea-bf30-43f2e9fc32b4
Public Version Date
February 21, 2022
Public Version Number
5
DI Record Publish Date
March 05, 2020
Package DI Number
00190509001674
Quantity per Package
30
Contains DI Package
00190509001612
Package Discontinue Date
January 01, 2022
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 | 127 |