Duns Number:883492720
Device Description: Organic cotton non-applicator tampons, regular absorbency
Catalog Number
-
Brand Name
EMERITA
Version/Model Number
Non Applicator 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
HEB
Product Code Name
Tampon, Menstrual, Unscented
Public Device Record Key
c084565c-8862-4aa3-9c14-26cb5b46624f
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
September 19, 2017
Package DI Number
00356163161929
Quantity per Package
14
Contains DI Package
00356163513520
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 |