Duns Number:068331990
Catalog Number
-
Brand Name
DG Health Tampons
Version/Model Number
BDGPP18+3
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
f49de1b4-127d-446d-a1b2-c8502810e9e4
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
September 20, 2016
Package DI Number
10834533000513
Quantity per Package
6
Contains DI Package
00834533000516
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 |