Duns Number:081106256
Device Description: Sample pack contains: - Ultra Thin Organic Cotton Pad with Wings,1 unit - Ultra Thin Organ Sample pack contains: - Ultra Thin Organic Cotton Pad with Wings,1 unit - Ultra Thin Organic Cotton Liner, 1 unit - Organic Cotton Applicator Tampon Regular, 1 unit
Catalog Number
-
Brand Name
TOP
Version/Model Number
Sample pack
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
15e2b718-72a6-4e5a-bdab-2b7dae4f0e35
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
May 11, 2018
Package DI Number
10860495001367
Quantity per Package
30
Contains DI Package
00860495001360
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-