SpineSTAR® 3192/A

GUDID 10884450296001

Merit Medical Systems, Inc.

Radio-frequency ablation system

• Primary Device ID: 10884450296001
• NIH Device Record Key: 96cd9cf6-7c9c-44cb-b341-c2e2f5458287
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SpineSTAR®
• Version Model Number: 00884450296004
• Catalog Number: 3192/A
• Company DUNS: 184763290
• Company Name: Merit Medical Systems, Inc.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450296004 [Primary]
GS1	10884450296001 [Package]; Contains: 00884450296004; Package: [75 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091310

FDA Product Code

• GEI: Electrosurgical, cutting & coagulation & accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-22
• Device Publish Date: 2019-03-14

On-Brand Devices [SpineSTAR®]

• 10884450296094: 00884450296097
• 10884450296087: 00884450296080
• 10884450296001: 00884450296004
• 10884450296032: 00884450296035
• 00884450488553: 10884450488550
• 10884450488321: 00884450488324
• 00884450488560: 10884450488567
• 00884450587768: C