STAR Tumor Ablation Kit (10|15, Long) with PowerCURVE RF-1015L-01

GUDID 00850696006271

ala carte packaging

Dfine, Inc.

Radio-frequency ablation system

• Primary Device ID: 00850696006271
• NIH Device Record Key: 97f56b40-c0fe-4c8f-a37e-35c25680d728
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STAR Tumor Ablation Kit (10|15, Long) with PowerCURVE
• Version Model Number: RF-1015L-01
• Catalog Number: RF-1015L-01
• Company DUNS: 169957607
• Company Name: Dfine, 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850696006271 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-19
• Device Publish Date: 2016-08-23

On-Brand Devices [STAR Tumor Ablation Kit (10|15, Long) with PowerCURVE]

• 00850696006677: blister tray packaging
• 00850696006271: ala carte packaging