Duns Number:883492720
Device Description: Non Applicator multipack contains:- Organic Cotton Non Applicator Tampons Regular, 18 unit Non Applicator multipack contains:- Organic Cotton Non Applicator Tampons Regular, 18 units- Organic Cotton Non Applicator Tampons Super, 12 units- Organic Cotton Non Applicator Tampons Super Plus, 10 units
Catalog Number
-
Brand Name
EMERITA
Version/Model Number
Non Applicator Multipack
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
d1dda6f4-e54e-4b22-8889-838620b4221d
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
September 28, 2017
Package DI Number
00356163766407
Quantity per Package
7
Contains DI Package
00356163832119
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 |