OneStic Micro-Access Introducer 497821

GUDID 10886333223753

OneStic Micro-Access Introducer 4F

ARGON MEDICAL DEVICES, INC.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 10886333223753
• NIH Device Record Key: d008e21f-48c6-4f3d-910e-d6cd04cbd085
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneStic Micro-Access Introducer
• Version Model Number: 497821
• Catalog Number: 497821
• 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	00886333223756 [Primary]
GS1	10886333223753 [Package]; Contains: 00886333223756; Package: Box [10 Units]; In Commercial Distribution
GS1	20886333223750 [Package]; Contains: 00886333223756; Package: Box [50 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: 2017-06-27

On-Brand Devices [OneStic Micro-Access Introducer]

• 10886333223968: 4F OneStic Micro-Access Introducer
• 10886333223951: 6F OneStic Micro-Access Introducer
• 10886333223944: 7F OneStic Micro-Access Introducer
• 10886333223937: 6F OneStic Micro-Access Introducer
• 10886333223890: OneStic Micro-Access Introducer 5F
• 10886333223883: OneStic Micro-Access Introducer 6F
• 10886333223876: OneStic Micro-Access Introducer 6F
• 10886333223869: OneStic Micro-Access Introducer 4F
• 10886333223852: OneStic Micro-Access Introducer 7F
• 10886333223845: OneStic Micro-Access Introducer 7F
• 10886333223821: OneStic Micro-Access Introducer 7F
• 10886333223814: OneStic Micro-Access Introducer 5F
• 10886333223807: OneStic Micro-Access Introducer 6F
• 10886333223791: OneStic Micro-Access Introducer 8F
• 10886333223784: OneStic Micro-Access Introducer 6F
• 10886333223777: OneStic Micro-Access Introducer 6F
• 10886333223760: OneStic Micro-Access Introducer 5F
• 10886333223753: OneStic Micro-Access Introducer 4F
• 10886333223746: OneStic Micro-Access Introducer 6F
• 10886333223739: OneStic Micro-Access Introducer 6F
• 10886333223722: OneStic Micro-Access Introducer 6F
• 10886333223715: OneStic Micro-Access Introducer 4F
• 10886333223708: OneStic Micro-Access Introducer 7F
• 10886333223692: OneStic Micro-Access Introducer 8F
• 10886333223685: OneStic Micro-Access Introducer 5F
• 10886333224668: 7F OneStic Micro-Access Introducer