STAR™ RF-0510S-01/C

GUDID 00884450379875

Merit Medical Systems, Inc.

Radio-frequency ablation system

• Primary Device ID: 00884450379875
• NIH Device Record Key: 046818b4-cf67-4629-8590-14f26c2e44cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STAR™
• Version Model Number: 00884450379875
• Catalog Number: RF-0510S-01/C
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450379875 [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: 2018-10-18
• Device Publish Date: 2018-09-17

On-Brand Devices [STAR™]

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