Duns Number:076059836
Catalog Number
-
Brand Name
Good Sense
Version/Model Number
BUSGSSMXR24
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
HHD
Product Code Name
Pad, Menstrual, Unscented
Public Device Record Key
69f048ba-f8fb-48d3-aa23-08f00d4a8b22
Public Version Date
June 09, 2020
Public Version Number
1
DI Record Publish Date
June 01, 2020
Package DI Number
10846036000136
Quantity per Package
12
Contains DI Package
00846036000139
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 | 5 |
2 | A medical device with a moderate to high risk that requires special controls. | 14 |