Duns Number:178161212
Device Description: Maxi Pad, Regular
Catalog Number
732913450008
Brand Name
Seventh Generation
Version/Model Number
Pad Maxi, Regular
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
42141021-9d58-467b-9c3b-52422dabef66
Public Version Date
May 23, 2019
Public Version Number
2
DI Record Publish Date
September 21, 2018
Package DI Number
10732913450005
Quantity per Package
12
Contains DI Package
00732913450008
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1 |