Duns Number:006961411
Device Description: Multipack of 18 tampons - 9 Regular absorbency and 9 Super absorbency
Catalog Number
-
Brand Name
Equaline Tampons
Version/Model Number
BSVXC18
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
b1eac624-833c-4d59-a5a1-3821947dfb53
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
May 02, 2017
Package DI Number
10041163499154
Quantity per Package
12
Contains DI Package
00041163499157
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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |