The Fischer

GUDID 04260587510200

Tap Water Iontophoresis Device for Treatment of Hyperhidrosis (Hands and Feet)

Saalmann medical GmbH & Co. KG

Hyperhidrosis iontophoresis system

• Primary Device ID: 04260587510200
• NIH Device Record Key: 972650c9-3e5d-49ab-8f28-a7e09a4a4d87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: The Fischer
• Version Model Number: 07-80-000-09
• Company DUNS: 313291191
• Company Name: Saalmann medical GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• 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: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: +495731254500
• Email: info@saalmann-medical.de

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260587510200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191436

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: 2020-03-23
• Device Publish Date: 2020-03-15