Duns Number:072943876
Device Description: Multi pack of 34 - 17 Regular and 17 Super absorbency
Catalog Number
-
Brand Name
TopCare Tampons
Version/Model Number
BTCUC34
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
71abb310-be49-4664-b3f8-fe63dffa5dea
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
January 03, 2018
Package DI Number
10036800441405
Quantity per Package
6
Contains DI Package
00036800441408
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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 1 |