Percutaneous Introducer M490545

GUDID 20886333216493

Percutaneous Introducer with Depth Marks 5F x 45cm

ARGON MEDICAL DEVICES, INC.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 20886333216493
• NIH Device Record Key: ac09f371-19d3-46bd-a4f9-75636fb09b51
• Commercial Distribution Discontinuation: 2019-06-03
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Percutaneous Introducer
• Version Model Number: M490545
• Catalog Number: M490545
• Company DUNS: 140727624
• Company Name: ARGON MEDICAL DEVICES, 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: true
• 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: 1.800.927.4669
• 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	00886333216499 [Primary]
GS1	20886333216493 [Package]; Contains: 00886333216499; Package: Box [10 Units]; Discontinued: 2019-06-03; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K780126

FDA Product Code

• DRE: Dilator, Vessel, For Percutaneous Catheterization

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-06-07
• Device Publish Date: 2016-09-21

On-Brand Devices [Percutaneous Introducer]

• 20886333216509: Percutaneous Introducer with Depth Marks 5F x 65cm
• 20886333216493: Percutaneous Introducer with Depth Marks 5F x 45cm
• 20886333216486: Percutaneous Introducer with Depth Marks 4F x 65cm
• 20886333216479: Percutaneous Introducer with Depth Marks 4F x 45cm
• 20886333227420: Percutaneous Introducer with Depth Marks 4F x 65cm
• 20886333227413: Percutaneous Introducer with Depth Marks 4F x 45cm
• 20886333227406: Percutaneous Introducer with Depth Marks 4F x 65cm
• 20886333227390: Percutaneous Introducer with Depth Marks 4F x 45cm
• 20886333227383: Percutaneous Introducer with Depth Marks 4F x 25cm