Moisyn Dry Mouth Oral Rinse - Moisyn is a specifically formulated - SYNEDGEN, INC.

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

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Moisyn Dry Mouth Oral Rinse

Version/Model Number

300mL

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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"

Yes

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

K173237

Product Code Details

Product Code

LFD

Product Code Name

Saliva, Artificial

Device Record Status

Public Device Record Key

a27efd8d-9e7d-4cae-a6cf-85f6ee63d6af

Public Version Date

December 30, 2020

Public Version Number

1

DI Record Publish Date

December 22, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SYNEDGEN, INC." Characteristics
Device Class Device Class Description No of Devices
U Unclassified 8