FDA.reportPublic FDA data

UnoDose Metered-Dose Topical Applicator

Primary DI
G5511070053
Brand
UnoDose Metered-Dose Topical Applicator
Company
Reflex Medical Corp.
Model
250-Pack PURPLE
Catalog number
1070-05
Device description
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.
Published
2023-10-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KYXDispenser, Liquid Medication

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYXDispenser, Liquid MedicationGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G5511070053PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Home-use transdermal medication applicatorA non-powered, non-absorbent, hand-held device designed to be used in the home for the topical application of a semi-solid transdermal medication (e.g., hormone gel, medicated cream) [not included] to the skin surface; it is intended to prevent contact between the medicated substance and the patient’s hands to reduce the risk of medication exposure in the environment. It is typically in the form of a cylinder with a smooth head on which the substance is dispensed prior to skin application. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-651-788-7907dann.gearhart@uno-dose.com

Regulatory Flags#

DUNS number
146548271
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G5511040022UnoDose Metered-Dose Topical Applicator100-Pack WHITE1040-022023-10-02
G5511040032UnoDose Metered-Dose Topical Applicator100-Pack PINK1040-032023-10-02
G5511040042UnoDose Metered-Dose Topical Applicator100-Pack GREEN2023-10-02
G5511040052UnoDose Metered-Dose Topical Applicator100-Pack PURPLE1040-052023-10-02
G5511040062UnoDose Metered-Dose Topical Applicator100-Pack GRAY1040-062023-10-02
G5511041064UnoDose Metered-Dose Topical Applicator200-Pack GRAY1041-062023-10-02
G5511070023UnoDose Metered-Dose Topical Applicator250-Pack WHITE1070-022023-10-02
G5511070033UnoDose Metered-Dose Topical Applicator250-Pack PINK1070-032023-10-02
G5511070043UnoDose Metered-Dose Topical Applicator250-Pack GREEN1070-042023-10-02
G5511070063UnoDose Metered-Dose Topical Applicator250-Pack GRAY1070-062023-10-02
G5511000021UnoDose Metered-Dose Topical Applicator25-Pack WHITE1000-022023-09-29
G5511000031UnoDose Metered-Dose Topical Applicator25-Pack Pink1000-032023-09-29
G5511000041UnoDose Metered-Dose Topical Applicator25-Pack GREEN1000-042023-09-29
G5511000051UnoDose Metered-Dose Topical Applicator25-Pack PURPLE1000-052023-09-29
G5511000061UnoDose Metered-Dose Topical Applicator25-Pack GRAY1000-062023-09-29

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