Duns Number:002347102
Device Description: LISTERINE SENSITIVITY ZERO ALCOHOL MOUTHRINSE FRESH MINT 250 ML
Catalog Number
-
Brand Name
Listerine
Version/Model Number
00312547235969
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 02, 2021
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
-
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
K143155
Product Code
LBH
Product Code Name
VARNISH, CAVITY
Public Device Record Key
0540bcc9-5494-4f6e-9e63-3634418fe678
Public Version Date
December 02, 2021
Public Version Number
7
DI Record Publish Date
December 10, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 307 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |