Duns Number:078740398
Device Description: Abena San Premium holds 22 fluid ounces/650 ml, for individuals for width and length measu Abena San Premium holds 22 fluid ounces/650 ml, for individuals for width and length measurements of 13x4".
Catalog Number
-
Brand Name
Abena
Version/Model Number
1000021305
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
Yes
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
0aaa95d1-e304-401f-a301-d44484b341c0
Public Version Date
August 16, 2022
Public Version Number
1
DI Record Publish Date
August 08, 2022
Package DI Number
05713571000533
Quantity per Package
7
Contains DI Package
05713571000526
Package Discontinue Date
January 01, 2023
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 | 127 |