Duns Number:001695568
Device Description: Multi pack of 40 tampons - 8 Light, 16 Regular and 16 Super absorbency
Catalog Number
-
Brand Name
Exchange Select Tampons
Version/Model Number
BAFAC40
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
9fc1cbc0-4482-435e-94a0-81d8342b4637
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
September 20, 2016
Package DI Number
10614299396408
Quantity per Package
12
Contains DI Package
00614299396401
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 | 17 |
2 | A medical device with a moderate to high risk that requires special controls. | 6 |