GLOBUS G5527

GUDID 08032625828037

The Globus Device is a programmable electro stimulator with multiple uses: Powered Muscle Stimulators, Transcutaneous Electrical Nerve Stimulator. Premodulated Current Therapy Stimulator, and Microcurrent Therapy Stimulator.

DOMINO SRL

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 08032625828037
• NIH Device Record Key: 15b3daa5-98cc-4f93-b9a7-30635c22feac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GLOBUS
• Version Model Number: GLOBUS PHOENIX WAVEFORM ELITE
• Catalog Number: G5527
• Company DUNS: 565257974
• Company Name: DOMINO SRL
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08032625828037 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071431

FDA Product Code

• GZJ: Stimulator, Nerve, Transcutaneous, For Pain Relief

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: 2024-10-25
• Device Publish Date: 2024-10-17

On-Brand Devices [GLOBUS]

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• 08032625827559: The Globus Premium Sport and Fitness Devices are programmable muscle stimulators. Each device in
• 08032625827528: The Globus Premium Sport and Fitness Devices are programmable muscle stimulators. Each device in
• 08032625825265: The Globus Genesy Device is a programmable electro stimulator with multiple uses: Powered Muscl
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• 08032625829812: The Globus Device is a programmable electro stimulator with multiple uses: Powered Muscle Stimu
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• 08032625829799: The Globus Device is a programmable electro stimulator with multiple uses: Powered Muscle Stimu
• 08032625829782: The Globus Premium Sport and Fitness Devices are programmable muscle stimulators. Each device in
• 08032625829775: The Globus Premium Sport and Fitness Devices are programmable muscle stimulators. Each device in
• 08032625828037: The Globus Device is a programmable electro stimulator with multiple uses: Powered Muscle Stimu
• 08032625827566: The Globus Premium Sport and Fitness Devices are programmable muscle stimulators. Each device in
• 08032625827535: The Globus Premium Sport and Fitness Devices are programmable muscle stimulators. Each device in
• 08032625824183: The Globus Premium Sport and Fitness Devices are programmable muscle stimulators. Each device in
• 08032625824138: The Globus Premium Sport and Fitness Devices are programmable muscle stimulators. Each device in
• 08032625822851: The Globus Device is a programmable electro stimulator with multiple uses: Powered Muscle Stimu
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• 08032625822875: The Globus ARPneuro device is a programmable electro stimulator with multiple uses: Powered Mus
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