Soleo Stim 5350

GUDID 04053815003328

Zimmer MedizinSysteme GmbH

Physical therapy electrical stimulation system, line-powered

• Primary Device ID: 04053815003328
• NIH Device Record Key: 79976af8-ea03-4a8c-a733-c30139f43800
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Soleo Stim
• Version Model Number: 5350
• Catalog Number: 5350
• Company DUNS: 316111251
• Company Name: Zimmer MedizinSysteme GmbH
• 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: false
• 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

Customer Support Contacts

• Phone: (800) 327-3576
• Email: info@zimmerusa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04053815003328 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121059

FDA Product Code

• LIH: Interferential Current Therapy

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

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