Duns Number:830276353
Device Description: Moisyn is a specifically formulated artificial saliva substitute which contains m Moisyn is a specifically formulated artificial saliva substitute which contains moisturizers, humectants, and biopolymers that are designed to relieve dry mouth symptoms, soothe irritated oral surfaces, refresh, clean, and lubricate.
Catalog Number
-
Brand Name
Moisyn Dry Mouth Oral Rinse
Version/Model Number
60ML
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 22, 2020
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)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K173237
Product Code
LFD
Product Code Name
Saliva, Artificial
Public Device Record Key
69cad6e9-a2c4-42a3-8dfb-475fbab7d65b
Public Version Date
December 23, 2020
Public Version Number
2
DI Record Publish Date
September 22, 2020
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 |
|---|---|---|
| U | Unclassified | 8 |