GLOBUS G6996

GUDID 08032625822882

The Globus Circuit Breaker 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: 08032625822882
• NIH Device Record Key: a558b236-c0b0-4ed3-8eba-67b7889f87d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GLOBUS
• Version Model Number: CIRCUIT BREAKER
• Catalog Number: G6996
• 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	08032625822882 [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: 2024-11-28
• Device Publish Date: 2024-11-20

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