Solero

GUDID H787127401380

Solero MTA Cart

ANGIODYNAMICS, INC.

Microwave hyperthermia system

• Primary Device ID: H787127401380
• NIH Device Record Key: c2fe6674-1cca-40ed-aaf4-d8008bbe2753
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solero
• Version Model Number: H787127401380
• Company DUNS: 079105071
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	15051684000512 [Secondary]
HIBCC	H787127401380 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182250

FDA Product Code

• NEY: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-13
• Device Publish Date: 2019-03-05

Devices Manufactured by ANGIODYNAMICS, INC.

• 15051684019019 - ADx Guidewire: 2024-11-19 GUIDEWIRE, PTFE 038 X 260CM FC ST
• H7878101351500 - ADx: 2024-11-12 GUIDEWIRE, PTFE 035 X 150CM FC ST
• H7878101352600 - ADx: 2024-11-12 GUIDEWIRE, PTFE 035 X 260CM FC ST
• H7878101381500 - ADx: 2024-11-12 GUIDEWIRE, PTFE 038 X 150CM FC ST
• H7878105251500 - ADx: 2024-11-12 GUIDEWIRE, PTFE 025 X 150CM FC 3MM J
• H7878105252600 - ADx: 2024-11-12 GUIDEWIRE, PTFE 025 X 260CM FC 3MM J
• H7878105321500 - ADx: 2024-11-12 GUIDEWIRE, PTFE 032 X 150CM FC 3MM J
• H7878105350800 - ADx: 2024-11-12 GUIDEWIRE, PTFE 035 X 80CM FC 3MM J