Duns Number:428129167
Catalog Number
-
Brand Name
ORGANYC
Version/Model Number
Applicator Super Plus
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
-
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
65c4e074-d3c8-4344-a744-2f11e78e577c
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
September 21, 2016
Package DI Number
38016867008991
Quantity per Package
6
Contains DI Package
08016867008990
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-