1 Piece Introducer w/ Micro Set 496613

GUDID 20886333214185

5F 1 Piece Introducer w/ Micro Set

ARGON MEDICAL DEVICES, INC.

Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable Vascular catheter introduction set, nonimplantable

• Primary Device ID: 20886333214185
• NIH Device Record Key: 3783997d-6030-4eee-8a48-cd94a0135abb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1 Piece Introducer w/ Micro Set
• Version Model Number: 496613
• Catalog Number: 496613
• Company DUNS: 140727624
• Company Name: ARGON MEDICAL DEVICES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com
• Phone: 1.800.927.4669
• Email: Customer.Service@argonmedical.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00886333214181 [Primary]
GS1	20886333214185 [Package]; Contains: 00886333214181; Package: Box [10 Units]; In Commercial Distribution

FDA Product Code

• OFL: Percutaneous Sheath Introducer Kit

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: 2019-06-07
• Device Publish Date: 2016-09-21

Devices Manufactured by ARGON MEDICAL DEVICES, INC.

• 00886333227167 - CLEANER Vac™: 2024-04-25 CLEANER Vac™ Thrombectomy System - 18F OD x 115cm
• 00886333227174 - Cleaner Vac™: 2024-04-25 Cleaner Vac™ - 18F OD x 115cm Aspiration Catheter with Handpiece
• 00886333227624 - Cleaner Vac™: 2024-04-25 Cleaner Vac™ Aspiration Canister
• 00886333225743 - Kodiak: 2023-07-10 Kodiak™ Dual Port Coaxial Introducer Kit
• 20886333227284 - Co-Axial Introducer Needle: 2023-06-16 Co-Axial Introducer Needle 15ga x 6.8cm
• 20886333227383 - Percutaneous Introducer: 2023-04-19 Percutaneous Introducer with Depth Marks 4F x 25cm
• 20886333227390 - Percutaneous Introducer: 2023-04-19 Percutaneous Introducer with Depth Marks 4F x 45cm
• 20886333227406 - Percutaneous Introducer: 2023-04-19 Percutaneous Introducer with Depth Marks 4F x 65cm