Identity
- Trade Name
- Moisyn Dry Mouth Oral Rinse FDA UDI
- Generic Name
- Artificial saliva FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 60ML FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852181005042 FDA UDI
- 510(k) Number
- K173237 FDA UDI
- FDA Product Code
- LFD FDA UDI
- GMDN Term
- Artificial saliva FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moisyn Dry Mouth Oral Rinse by Synedgen, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Synedgen, Inc.
Sources (1)
- FDA UDI 69cad6e9-a2c4-42a3-8dfb-475fbab7d65b 36 fields · synced Jun 8, 2026