MetaSTAR® 3195/A

GUDID 00884450296011

Merit Medical Systems, Inc.

Radio-frequency ablation system

• Primary Device ID: 00884450296011
• NIH Device Record Key: c5390306-05de-4c7e-803f-0dfd17738eaf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MetaSTAR®
• Version Model Number: 00884450296011
• Catalog Number: 3195/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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450296011 [Primary]

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: 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: 2017-05-09

Devices Manufactured by Merit Medical Systems, Inc.

• 00884450020647 - Merit Medical®: 2025-04-11
• 20884450014244 - Merit Medical®: 2025-04-10
• 20884450844469 - Prelude EASE™: 2025-04-10
• 00884450013496 - Merit Medical®: 2025-04-09
• 10884450792312 - DuraFlow™2: 2025-04-09
• 00884450793930 - BioFlo DuraMax®: 2025-04-09
• 20884450844759 - Prelude IDeal™: 2025-04-09
• 10884450860097 - AccessPLUS™: 2025-04-07