Duns Number:004238200
Device Description: L Tampon Full Size Mix Regular/Super
Catalog Number
-
Brand Name
This is L
Version/Model Number
L Tampon
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
6cb3173d-19cb-47d5-bae4-4d77df304932
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
June 12, 2020
Package DI Number
40073010714838
Quantity per Package
60
Contains DI Package
10073010714837
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pallet
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 241 |
| U | Unclassified | 1 |