DERMADRY FPRD-004

GUDID 00877067000010

DERMADRY TOTAL Tap Water Iontophoresis Device for treatment of hands, feet and underarms

Dermadry Laboratories Inc

Hyperhidrosis iontophoresis system

• Primary Device ID: 00877067000010
• NIH Device Record Key: 5b62255b-41c2-43d6-89cc-05d15ed80ab9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DERMADRY
• Version Model Number: TOTAL
• Catalog Number: FPRD-004
• Company DUNS: 203532858
• Company Name: Dermadry Laboratories Inc
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00877067000010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192749

FDA Product Code

• EGJ: Device, Iontophoresis, Other Uses

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-25
• Device Publish Date: 2020-03-17

On-Brand Devices [DERMADRY]

• 00877067000034: DERMADRY UNDERARMS Tap Water Iontophoresis Device for treatment of underarms
• 00877067000027: DERMADRY HANDS AND FEET Tap Water Iontophoresis Device for treatment of hands and feet
• 00877067000010: DERMADRY TOTAL Tap Water Iontophoresis Device for treatment of hands, feet and underarms