AccessGUDID - DEVICE: UnoDose Metered-Dose Topical Applicator (G5511040052)

GUDID

Device Identifier (DI) Information

Brand Name: UnoDose Metered-Dose Topical Applicator
Version or Model: 100-Pack PURPLE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1040-05
Company Name: Reflex Medical Corp.

Primary DI Number: G5511040052
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 146548271 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64370	Home-use transdermal medication applicator	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KYX	Dispenser, Liquid Medication

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8a09b32d-4aaf-4878-a060-7433044d0b83
Public Version Date: October 10, 2023
Public Version Number: 1
DI Record Publish Date: October 02, 2023