Duns Number:080438205
Device Description: Organic Cotton Cardboard Applicator Tampons
Catalog Number
-
Brand Name
DR. MERCOLA
Version/Model Number
Cardboard Applicator Tampons, Super
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
HEB
Product Code Name
Tampon, Menstrual, Unscented
Public Device Record Key
43ed0758-fe73-4e76-b888-7436ab29e570
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
December 28, 2020
Package DI Number
80813006012702
Quantity per Package
12
Contains DI Package
00813006012706
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Cardboard