VENISTAR

GUDID 18809306767865

STARMED CO.,LTD

Peripheral vascular radio-frequency ablation catheter

• Primary Device ID: 18809306767865
• NIH Device Record Key: c2930c8e-d604-4007-a93e-ab60263e1097
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VENISTAR
• Version Model Number: 3-VENI0030N
• Company DUNS: 694699723
• Company Name: STARMED CO.,LTD
• 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: true
• Expiration Date: true
• 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	08809306767868 [Primary]
GS1	18809306767865 [Package]; Contains: 08809306767868; Package: [5 Units]; In Commercial Distribution
GS1	28809306767862 [Package]; Contains: 08809306767868; Package: Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222997

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: 2024-09-06
• Device Publish Date: 2024-08-29

On-Brand Devices [VENISTAR]

• 18809306767872: 7-VENI0070N
• 18809306767865: 3-VENI0030N
• 18809306764871: 3-VENI003090N
• 18809306764017: 7-VENI007090N