UnoDose Metered-Dose Topical Applicator 1040-02

GUDID G5511040022

The UnoDose Applicator repeatedly dispenses a metered volume of therapeutic cream or gel for application to the skin. It also serves as a mixing container for compounding creams and gels with electronic mortar and pestle (EMP) systems.

Reflex Medical Corp.

Home-use transdermal medication applicator
Primary Device IDG5511040022
NIH Device Record Keyf11da1b1-1683-44c7-b9fb-a062b494d750
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnoDose Metered-Dose Topical Applicator
Version Model Number100-Pack WHITE
Catalog Number1040-02
Company DUNS146548271
Company NameReflex Medical Corp.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-651-788-7907
Emaildann.gearhart@uno-dose.com
Phone1-651-788-7907
Emaildann.gearhart@uno-dose.com
Phone1-651-788-7907
Emaildann.gearhart@uno-dose.com
Phone1-651-788-7907
Emaildann.gearhart@uno-dose.com
Phone1-651-788-7907
Emaildann.gearhart@uno-dose.com
Phone1-651-788-7907
Emaildann.gearhart@uno-dose.com
Phone1-651-788-7907
Emaildann.gearhart@uno-dose.com
Phone1-651-788-7907
Emaildann.gearhart@uno-dose.com
Phone1-651-788-7907
Emaildann.gearhart@uno-dose.com
Phone1-651-788-7907
Emaildann.gearhart@uno-dose.com
Phone1-651-788-7907
Emaildann.gearhart@uno-dose.com
Phone1-651-788-7907
Emaildann.gearhart@uno-dose.com
Phone1-651-788-7907
Emaildann.gearhart@uno-dose.com
Phone1-651-788-7907
Emaildann.gearhart@uno-dose.com
Phone1-651-788-7907
Emaildann.gearhart@uno-dose.com
Phone1-651-788-7907
Emaildann.gearhart@uno-dose.com
Phone1-651-788-7907
Emaildann.gearhart@uno-dose.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCG5511040022 [Primary]

FDA Product Code

KYXDispenser, Liquid Medication

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-10
Device Publish Date2023-10-02

On-Brand Devices [UnoDose Metered-Dose Topical Applicator]

G5511000061The UnoDose Applicator repeatedly dispenses a metered volume of therapeutic cream or gel for app
G5511000051The UnoDose Applicator repeatedly dispenses a metered volume of therapeutic cream or gel for app
G5511000041The UnoDose Applicator repeatedly dispenses a metered volume of therapeutic cream or gel for app
G5511000031The UnoDose Applicator repeatedly dispenses a metered volume of therapeutic cream or gel for app
G5511000021The UnoDose Applicator repeatedly dispenses a metered volume of therapeutic cream or gel for app
G5511070063The UnoDose Applicator repeatedly dispenses a metered volume of therapeutic cream or gel for app
G5511070053The UnoDose Applicator repeatedly dispenses a metered volume of therapeutic cream or gel for app
G5511070043The UnoDose Applicator repeatedly dispenses a metered volume of therapeutic cream or gel for app
G5511070033The UnoDose Applicator repeatedly dispenses a metered volume of therapeutic cream or gel for app
G5511070023The UnoDose Applicator repeatedly dispenses a metered volume of therapeutic cream or gel for app
G5511041064The UnoDose Applicator repeatedly dispenses a metered volume of therapeutic cream or gel for app
G5511040062The UnoDose Applicator repeatedly dispenses a metered volume of therapeutic cream or gel for app
G5511040052The UnoDose Applicator repeatedly dispenses a metered volume of therapeutic cream or gel for app
G5511040042The UnoDose Applicator repeatedly dispenses a metered volume of therapeutic cream or gel for app
G5511040032The UnoDose Applicator repeatedly dispenses a metered volume of therapeutic cream or gil for app
G5511040022The UnoDose Applicator repeatedly dispenses a metered volume of therapeutic cream or gel for app

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