Duns Number:175425982
Device Description: 18 ct Combo Reg Tampon, Super Pad
Catalog Number
999-001-07
Brand Name
Pill Club
Version/Model Number
Period Care Combo Tampons
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
Yes
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
9f654e37-f3d8-454d-a385-9b419f73666f
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
February 09, 2022
Package DI Number
20060004693572
Quantity per Package
1
Contains DI Package
00860004693574
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Plastic Pouch
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |