Alatus

GUDID 15051684018913

Alatus Vaginal Balloon Packing System

ANGIODYNAMICS, INC.

Radiation therapy lesion localization urethral catheter, planning

• Primary Device ID: 15051684018913
• NIH Device Record Key: 9f337522-a769-481e-b5a9-fea3db11a0f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alatus
• Version Model Number: VBP-40
• Company DUNS: 079105071
• Company Name: ANGIODYNAMICS, 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
• 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	15051684018913 [Secondary]
HIBCC	H787VBP400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092534

FDA Product Code

• JAQ: System, applicator, radionuclide, remote-controlled

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: 2024-01-10
• Device Publish Date: 2024-01-02

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• 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