Soleo Sono 5345

GUDID 04053815003311

Zimmer MedizinSysteme GmbH

Physical therapy ultrasound system

• Primary Device ID: 04053815003311
• NIH Device Record Key: e9f19c25-a719-4f4a-b58d-8abc5333db23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Soleo Sono
• Version Model Number: 5345
• Catalog Number: 5345
• 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	04053815003311 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121059

FDA Product Code

• IMI: Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

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

Devices Manufactured by Zimmer MedizinSysteme GmbH

• 04053815087410 - ZStim: 2024-08-06
• 04053815086369 - ZShape: 2024-07-29
• 04053815087229 - Cryo 7: 2024-06-04
• 04053815076711 - MFG-05: 2023-10-24
• 04053815081296 - ThermoTK: 2023-06-13
• 04053815083344 - clTrac: 2023-06-13
• 04053815078562 - emField: 2022-05-19
• 04053815080848 - Cryo 7: 2022-03-09