Duns Number:316433234
Device Description: ASSURED hygiene pad normal
Catalog Number
-
Brand Name
ASSURED
Version/Model Number
normal
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
714963e3-f023-4c08-8ad0-5129789a127f
Public Version Date
June 26, 2020
Public Version Number
2
DI Record Publish Date
April 15, 2020
Package DI Number
04000576013868
Quantity per Package
12
Contains DI Package
04009408027202
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1 |