One Step Micro-Introducer System 497846

GUDID 10886333215178

One Step Micro-Introducer System 7F

ARGON MEDICAL DEVICES, INC.

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• Primary Device ID: 10886333215178
• NIH Device Record Key: b8f66ec8-a231-4f34-b2bc-18d83582b446
• Commercial Distribution Discontinuation: 2017-08-07
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: One Step Micro-Introducer System
• Version Model Number: 497846
• Catalog Number: 497846
• 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	00886333215171 [Primary]
GS1	10886333215178 [Package]; Contains: 00886333215171; Package: Box [10 Units]; Discontinued: 2017-08-07; Not in Commercial Distribution
GS1	20886333215175 [Package]; Contains: 00886333215171; Package: Box [50 Units]; Discontinued: 2017-08-07; 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: 4
• Public Version Date: 2019-06-07
• Device Publish Date: 2016-09-20

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• 10886333215314: One Step Micro-Introducer System 8F
• 10886333215307: One Step Micro-Introducer System 7F
• 10886333215291: One Step Micro-Introducer System 7F
• 10886333215284: One Step Micro-Introducer System 5F
• 10886333215277: One Step Micro-Introducer System 4F
• 10886333215260: One Step Micro-Introducer System 4F
• 10886333215253: One Step Micro-Introducer System 6F
• 10886333215246: One Step Micro-Introducer System 6F
• 10886333215239: One Step Micro-Introducer System 6F
• 10886333215222: One Step Micro-Introducer System 6F
• 10886333215215: One Step Micro-Introducer System 8F
• 10886333215192: One Step Micro-Introducer System 6F
• 10886333215178: One Step Micro-Introducer System 7F
• 10886333215154: One Step Micro-Introducer System 6F
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• 10886333215130: One Step Micro-Introducer System 6F
• 10886333215123: One Step Micro-Introducer System 5F
• 10886333215116: One Step Micro-Introducer System 5F
• 10886333215093: One Step Micro-Introducer System 4F