Solero

GUDID H787127401380

Solero MTA Cart

ANGIODYNAMICS, INC.

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• 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

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