StarBurst

GUDID H7877001024411

RITA StarBurst MRI Electrosurgical Device

NAVILYST MEDICAL, INC.

Percutaneous electrosurgical probe, tumour-ablation, monopolar Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar

• Primary Device ID: H7877001024411
• NIH Device Record Key: d157d155-6b32-4e9f-9c32-687db118d417
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StarBurst
• Version Model Number: 700-102441
• Company DUNS: 809699023
• Company Name: NAVILYST MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Device Dimensions

• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter
• Length: 10 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	15051684021425 [Secondary]
HIBCC	H7877001024411 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023846

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: 2019-04-23
• Device Publish Date: 2016-09-23

On-Brand Devices [StarBurst]

• H7877001040771: RITA StarBurst Xli Enhanced Semi-Flex Electrosurgical Device
• H7877001039091: RITA StarBurst MRI Semi-Flex Electrosurgical Device
• H7877001039081: RITA StarBurst SDE Electrosurgical Device
• H7877001039031: RITA StarBurst XL Electrosurgical Device
• H7877001039021: RITA StarBurst XL Electrosurgical Device
• H7877001039011: RITA StarBurst XL Electrosurgical Device
• H7877001030271: RITA StarBurst Xli Enhanced Electrosurgical Device
• H7877001030241: RITA StarBurst Xli Enhanced Electrosurgical Device
• H7877001026151: RITA StarBurst MRI Semi-Flex Electrosurgical Device
• H7877001024861: RITA StarBurst SDE Electrosurgical Device
• H7877001024411: RITA StarBurst MRI Electrosurgical Device
• H7877001024211: RITA StarBurst MRI Electrosurgical Device
• H7877001019301: RITA StarBurst XL Electrosurgical Device
• H7877001014921: RITA StarBurst Electrosurgical Device
• H7877001013201: RITA StarBurst XL Electrosurgical Device
• H7877001013171: RITA StarBurst XL Electrosurgical Device