Duns Number:480420090
Device Description: Effervescent Mouth Wash Tablets (1000 pieces)Effervescent Mouth Wash Tablets are pink pepp Effervescent Mouth Wash Tablets (1000 pieces)Effervescent Mouth Wash Tablets are pink peppermint flavoured tablets used for the preparation of a deodorizing mouth wash and for the removal of food debris.
Catalog Number
-
Brand Name
Effervescent Mouth Wash Tablets (1000 pieces)
Version/Model Number
66303
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EFT
Product Code Name
Cleanser, Denture, Over The Counter
Public Device Record Key
3c4bda19-853b-43b0-8957-27efc8012dfe
Public Version Date
June 21, 2022
Public Version Number
1
DI Record Publish Date
June 13, 2022
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 | 278 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |