DERMADRY

Basic Information

• Brand Name: DERMADRY
• Primary DI: 00877067000263
• Version / Model: HANDS AND FEET
• Catalog Number: FPRD-005
• Company Name: Dermadry Laboratories Inc
• Labeler DUNS: 203532858
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-17
• Public Version: 3
• Public Version Date: 2023-07-21
• Public Version Status: Update
• Public Device Record Key: 40096770-9d07-42cd-b0c1-7f57ace0db65

Device Description

DERMADRY HANDS AND FEET Tap Water Iontophoresis Device for treatment of hands and feet

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: Yes

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EGJ	Device, Iontophoresis, Other Uses	Physical Medicine	890.5525	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17421	Hyperhidrosis iontophoresis system	An assembly of electrically-powered devices intended to be used to transport ions in tap water (water from a faucet) and/or a water solution (e.g., glycopyrrolate and aluminium chloride) to the sweat ducts of heavy sweating areas of the body (e.g., hands, underarms, or feet) in patients that suffer from excessive perspiration (hyperhidrosis) to help minimize or stop sweating. Hyperkeratotic plugs develop in the sweat ducts as a result of the currents and hyperhidrosis is controlled.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00877067000263	GS1

Premarket Submissions

Submission Number	Supplement Number
K192749	000

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: .7 – 1.06 KiloPascal
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: .7 – 1.06 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 30 – 70 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 30 – 70 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -25 – 70 Degrees Celsius