Duns Number:068331990
Device Description: Multipack of 36 tampons, 20 Regular, 8 Super and 8 Super plus absorbency
Catalog Number
-
Brand Name
DG Health
Version/Model Number
BDGGC(R/S/P)36
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
5e95fd3b-2552-466e-8917-d6b082c896ab
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
September 18, 2021
Package DI Number
10834533001398
Quantity per Package
3
Contains DI Package
00834533001391
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 |