Duns Number:068331990
Device Description: regular plastic applicator tampons unscented
Catalog Number
-
Brand Name
DG Health Tampons
Version/Model Number
10005132
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
acb4c883-918f-4c10-bf88-ea94ff1d689f
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
March 27, 2020
Package DI Number
10748364500954
Quantity per Package
6
Contains DI Package
00748364500957
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 |