STAR™ RF-1015S-01/B

GUDID 00884450320648

Merit Medical Systems, Inc.

Radio-frequency ablation system

• Primary Device ID: 00884450320648
• NIH Device Record Key: 8cd3d246-9053-42ff-a2a7-78f6d997d0fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STAR™
• Version Model Number: 00884450320648
• Catalog Number: RF-1015S-01/B
• 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: true
• 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

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450320648 [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: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-15
• Device Publish Date: 2018-09-13

On-Brand Devices [STAR™]

• 00884450379899: 00884450379899
• 00884450379882: 00884450379882
• 00884450379875: 00884450379875
• 00884450320686: 00884450320686
• 00884450320679: 00884450320679
• 00884450320662: 00884450320662
• 00884450320655: 00884450320655
• 00884450320648: 00884450320648