Vessel Dilator 392354

GUDID 10886333210432

Vessel Dilator 4 French

ARGON MEDICAL DEVICES, INC.

Fascial tissue dilator, single-use

• Primary Device ID: 10886333210432
• NIH Device Record Key: e6d164a6-fdb5-40d2-a11e-5e7038c3243c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vessel Dilator
• Version Model Number: 392354
• Catalog Number: 392354
• 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: false
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	00886333210435 [Primary]
GS1	10886333210432 [Package]; Contains: 00886333210435; 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-10

On-Brand Devices [Vessel Dilator]

• 10886333216205: Vessel Dilator with Feathered Tip 7 French
• 10886333210432: Vessel Dilator 4 French
• 10886333210425: Vessel Dilator 5 French
• 10886333210418: Vessel Dilator 9 French
• 10886333210401: Vessel Dilator 8 French
• 10886333210395: Vessel Dilator 8 French
• 10886333210388: Vessel Dilator 7 French
• 10886333210371: Vessel Dilator 6 French
• 10886333210364: Vessel Dilator 6 French
• 10886333210357: Vessel Dilator 5 French
• 10886333210340: Vessel Dilator 5 French
• 10886333210333: Vessel Dilator 4 French
• 10886333210326: Vessel Dilator 4 French
• 10886333210319: Vessel Dilator 4 French