Duns Number:002347102
Device Description: LISTERINE ULTRACLEAN FLOSS 30 YARD
Catalog Number
-
Brand Name
Listerine
Version/Model Number
00012547440133
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 02, 2022
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JES
Product Code Name
FLOSS, DENTAL
Public Device Record Key
f460cb8a-5992-4dab-a8c4-abf9063e7387
Public Version Date
May 02, 2022
Public Version Number
4
DI Record Publish Date
September 12, 2018
Package DI Number
00012547115529
Quantity per Package
6
Contains DI Package
00012547440133
Package Discontinue Date
April 20, 2021
Package Status
Not in Commercial Distribution
Package Type
Shrink Wrap
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 |