SYNEDGEN INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30086630703008663070SYNEDGEN INC.1N2020-04-251420 N Claremont Blvd Suite 105D Claremont CA US 91711

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00852181005042Moisyn Dry Mouth Oral Rinse - 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.855-774-7962info@synedgen.com
00852181005059Moisyn Dry Mouth Oral Mist - 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.855-774-7962info@prisyna.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2101831597059466K173237Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral MistLFD2018-03-19
2101832025009174K172338Catasyn Advanced Technology Wound HydrogelFRO2018-02-21
2101831829273360K143444SynePure Wound CleanserFRO2015-08-21

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FRO22018-02-21
LFD12018-03-19

PMN#

GUDID#

Catasyn (3oz) - Catasyn OTC is indicated for the dressing and management of minor burns, minor cuts, minor lacerations, minor abrasions, and minor irritations of the skin.Catasyn may be used under the direction of a health care professional for the dressing and management of partial to full thickness dermal ulcers (pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers), surgical wounds (postoperative incisions and donor sites) and superficial and partial thickness (second degree) burns.

SYNEDGEN, INC.

2021-03-01