StarBurst

GUDID H7877001023300

Starburst Access System

ANGIODYNAMICS, INC.

Radio-frequency ablation system Non-vascular catheter introduction set Non-vascular catheter introduction set Non-vascular catheter introduction set Non-vascular catheter introduction set Non-vascular catheter introduction set Non-vascular catheter introduction set Non-vascular catheter introduction set Non-vascular catheter introduction set Non-vascular catheter introduction set Non-vascular catheter introduction set Non-vascular catheter introduction set Non-vascular catheter introduction set Non-vascular catheter introduction set Non-vascular catheter introduction set Non-vascular catheter introduction set Non-vascular catheter introduction set Non-vascular catheter introduction set Non-vascular catheter introduction set Non-vascular catheter introduction set Non-vascular catheter introduction set Non-vascular catheter introduction set Non-vascular catheter introduction set Non-vascular catheter introduction set Non-vascular catheter introduction set Non-vascular catheter introduction set Non-vascular catheter introduction set Non-vascular catheter introduction set Non-vascular catheter introduction set Non-vascular catheter introduction set Non-vascular catheter introduction set Non-vascular catheter introduction set Non-vascular catheter introduction set Non-vascular catheter introduction set Non-vascular catheter introduction set

• Primary Device ID: H7877001023300
• NIH Device Record Key: 657ef51c-7177-4c80-866f-07d28081b5a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StarBurst
• Version Model Number: 700102330
• Company DUNS: 601994184
• Company Name: ANGIODYNAMICS, 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: 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

Customer Support Contacts

• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com

Device Dimensions

• Length: 6 Centimeter
• Length: 6 Centimeter
• Length: 6 Centimeter
• Length: 6 Centimeter
• Length: 6 Centimeter
• Length: 6 Centimeter
• Length: 6 Centimeter
• Length: 6 Centimeter
• Length: 6 Centimeter
• Length: 6 Centimeter
• Length: 6 Centimeter
• Length: 6 Centimeter
• Length: 6 Centimeter
• Length: 6 Centimeter
• Length: 6 Centimeter
• Length: 6 Centimeter
• Length: 6 Centimeter
• Length: 6 Centimeter
• Length: 6 Centimeter
• Length: 6 Centimeter
• Length: 6 Centimeter
• Length: 6 Centimeter
• Length: 6 Centimeter
• Length: 6 Centimeter
• Length: 6 Centimeter
• Length: 6 Centimeter
• Length: 6 Centimeter
• Length: 6 Centimeter
• Length: 6 Centimeter
• Length: 6 Centimeter
• Length: 6 Centimeter
• Length: 6 Centimeter
• Length: 6 Centimeter
• Length: 6 Centimeter
• Length: 6 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	15051684019811 [Secondary]
HIBCC	H7877001023300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040989
• Premarket Notification: K983871

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

On-Brand Devices [StarBurst]

• H7877001039071: RITA StarBurst MRI Electrosurgical Device
• H7877001039061: RITA StarBurst MRI Electrosurgical Device
• H7877001039051: RITA StarBurst Electrosurgical Device
• H7877001039041: RITA StarBurst Electrosurgical Device
• H7877001014931: RITA StarBurst Electrosurgical Device
• H7877001023311: Starburst Access System
• H7877001023300: Starburst Access System