Duns Number:068331990
Device Description: regular scented plastic applicator tampons
Catalog Number
-
Brand Name
DG Health Tampons
Version/Model Number
DG12006S0/4
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K050067,K050067,K050067
Product Code
HIL
Product Code Name
Tampon, Menstrual, Scented, Deodorized
Public Device Record Key
04deb7a9-55c6-403d-aafc-53290508d676
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
September 07, 2016
Package DI Number
10748364500428
Quantity per Package
6
Contains DI Package
00748364500421
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 15 |
2 | A medical device with a moderate to high risk that requires special controls. | 9 |
U | Unclassified | 1 |