NAMIC

GUDID H965800450750

NEEDLE GUIDEWIRE INTRODUCER - OEM

ANGIODYNAMICS, INC.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: H965800450750
• NIH Device Record Key: 2c479597-8a5a-492d-9207-994480fc33d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NAMIC
• Version Model Number: 80045075
• 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: true
• Lot Batch: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H965800450750 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K903606

FDA Product Code

• LIT: Catheter, angioplasty, peripheral, transluminal

Sterilization

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

[H965800450750]

Ethylene Oxide

[H965800450750]

Ethylene Oxide

[H965800450750]

Ethylene Oxide

[H965800450750]

Ethylene Oxide

[H965800450750]

Ethylene Oxide

[H965800450750]

Ethylene Oxide

[H965800450750]

Ethylene Oxide

[H965800450750]

Ethylene Oxide

[H965800450750]

Ethylene Oxide

[H965800450750]

Ethylene Oxide

[H965800450750]

Ethylene Oxide

[H965800450750]

Ethylene Oxide

[H965800450750]

Ethylene Oxide

[H965800450750]

Ethylene Oxide

[H965800450750]

Ethylene Oxide

[H965800450750]

Ethylene Oxide

[H965800450750]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-03-20
• Device Publish Date: 2020-11-03

Devices Manufactured by ANGIODYNAMICS, INC.

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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
• 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