Navylist

GUDID 25051684023792

GUIDEWIRE, 0.018 X 65CM Ni/Tu

Angiodynamics, Inc.

Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 25051684023792
• NIH Device Record Key: 8df63a34-305d-458a-9155-bab84abcb707
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Navylist
• Version Model Number: 48-108
• Company DUNS: 079252781
• 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: 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(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com
• Phone: +1(800)772-6446
• Email: customerservice@angiodynamics.com

Device Dimensions

• Outer Diameter: 0.018 Inch
• Length: 65 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 65 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 65 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 65 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 65 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 65 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 65 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 65 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 65 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 65 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 65 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 65 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	15051684023795 [Primary]
GS1	25051684023792 [Package]; Contains: 15051684023795; Package: BX [10 Units]; In Commercial Distribution
HIBCC	H965481080 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170775

FDA Product Code

• DYB: Introducer, catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-28
• Device Publish Date: 2024-10-18

Devices Manufactured by Angiodynamics, Inc.

• 15051684016858 - BioFlo Vortex: 2024-11-27 SmartPort+ Standard Port with Endexo and Vortex Technology
• 15051684016865 - BioFlo Vortex: 2024-11-27 SmartPort+ Standard Port with Endexo and Vortex Technology
• 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