Duns Number:600487813
Device Description: FW PLASTIC TAMPON REGULAR 18CT
Catalog Number
-
Brand Name
Family Wellness Tampons
Version/Model Number
BFDPR18
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
b0eb9494-fd7d-40a1-897f-a84f0e7d6f97
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
July 23, 2017
Package DI Number
10032251114257
Quantity per Package
6
Contains DI Package
00032251114250
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. | 11 |