One-Piece/Tuohy-Borst Introducer Tray 497456

GUDID 20886333214642

One-Piece/Tuohy-Borst Introducer Tray 9F

ARGON MEDICAL DEVICES, INC.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 20886333214642
• NIH Device Record Key: 7339e7c0-3d22-48e1-93b7-dda2fe79744c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: One-Piece/Tuohy-Borst Introducer Tray
• Version Model Number: 497456
• Catalog Number: 497456
• 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: 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	00886333214648 [Primary]
GS1	20886333214642 [Package]; Contains: 00886333214648; Package: Box [10 Units]; 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: 4
• Public Version Date: 2019-06-07
• Device Publish Date: 2016-09-16

On-Brand Devices [One-Piece/Tuohy-Borst Introducer Tray]

• 20886333224214: One-Piece/Tuohy-Borst Introducer Tray without Lidocaine
• 20886333214963: One-Piece/Tuohy-Borst Introducer Tray 8.5F
• 20886333214642: One-Piece/Tuohy-Borst Introducer Tray 9F
• 20886333214635: One-Piece/Tuohy-Borst Introducer Tray 8.5F
• 20886333214628: One-Piece/Tuohy-Borst Introducer Tray 8F
• 20886333214611: One-Piece/Tuohy-Borst Introducer Tray 7F
• 20886333214604: One-Piece/Tuohy-Borst Introducer Tray 6F