Solero

GUDID H787700106003US0

Microwave Tissue Ablation Applicator

NAVILYST MEDICAL, INC.

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• Primary Device ID: H787700106003US0
• NIH Device Record Key: 9952a626-1105-4745-afe2-6701cc49a69c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solero
• Version Model Number: 700106003-US
• Company DUNS: 809699023
• Company Name: NAVILYST MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Device Dimensions

• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter
• Length: 29 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	15051684017862 [Secondary]
HIBCC	H787700106003US0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162449

FDA Product Code

• NEY: SYSTEM, ABLATION, MICROWAVE AND 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: 2017-05-10

On-Brand Devices [Solero]

• H787700106003US0: Microwave Tissue Ablation Applicator
• H787700106002US0: Microwave Tissue Ablation Applicator
• H787700106001US0: Microwave Tissue Ablation Applicator
• H78712740000US0: MTA System