CryoOne 5115

GUDID 04053815079163

Zimmer MedizinSysteme GmbH

Cold-air therapy unit Cold-air therapy unit Cold-air therapy unit Cold-air therapy unit Cold-air therapy unit Cold-air therapy unit Cold-air therapy unit Cold-air therapy unit Cold-air therapy unit Cold-air therapy unit Cold-air therapy unit Cold-air therapy unit Cold-air therapy unit Cold-air therapy unit Localized cutaneous/musculoskeletal cryotherapy unit Localized cutaneous/musculoskeletal cryotherapy unit Localized cutaneous/musculoskeletal cryotherapy unit Localized cutaneous/musculoskeletal cryotherapy unit Localized cutaneous/musculoskeletal cryotherapy unit Localized cutaneous/musculoskeletal cryotherapy unit Localized cutaneous/musculoskeletal cryotherapy unit Localized cutaneous/musculoskeletal cryotherapy unit Localized cutaneous/musculoskeletal cryotherapy unit Localized cutaneous/musculoskeletal cryotherapy unit Localized cutaneous/musculoskeletal cryotherapy unit

• Primary Device ID: 04053815079163
• NIH Device Record Key: 4e84ad66-b805-4828-bafb-dc7d0872c856
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CryoOne
• Version Model Number: 5115
• Catalog Number: 5115
• 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
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com
• Phone: (800) 327-3576
• Email: info@zimmerusa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04053815079163 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060395

FDA Product Code

• GEX: Powered Laser Surgical Instrument

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: 2020-07-13
• Device Publish Date: 2020-07-05

Devices Manufactured by Zimmer MedizinSysteme GmbH

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• 04053815081296 - ThermoTK: 2023-06-13
• 04053815083344 - clTrac: 2023-06-13
• 04053815078562 - emField: 2022-05-19
• 04053815080848 - Cryo 7: 2022-03-09
• 24053815072915 - Zimmertrodes: 2021-03-18
• 24053815072922 - Zimmertrodes: 2021-03-18
• 24053815072939 - Zimmertrodes: 2021-03-18