Duns Number:503650061
Device Description: Organic Cotton Tampon, Menstrual, Unscented with Applicator Super16 single use tampons per Organic Cotton Tampon, Menstrual, Unscented with Applicator Super16 single use tampons per pack
Catalog Number
-
Brand Name
Natracare
Version/Model Number
Tampons with Applicator 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
K954942,K954942,K954942
Product Code
HEB
Product Code Name
Tampon, Menstrual, Unscented
Public Device Record Key
ce91ec54-7299-4c2c-b052-b604a93f8406
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
September 22, 2016
Package DI Number
05019493090028
Quantity per Package
12
Contains DI Package
00782126009005
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton