Duns Number:068331990
Device Description: multi pack plastic applicator
Catalog Number
-
Brand Name
DG Health Tampons
Version/Model Number
DG63603U0/1
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
-
Product Code
HEB
Product Code Name
Tampon, Menstrual, Unscented
Public Device Record Key
6d514ad1-0efd-4b7e-963e-1600de8eda78
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
September 07, 2016
Package DI Number
10748364103070
Quantity per Package
3
Contains DI Package
00748364103073
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 |