One-Piece Introducer Tray 494435

GUDID 20886333213232

One-Piece Introducer Tray 8.5F

ARGON MEDICAL DEVICES, INC.

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Primary Device ID	20886333213232
NIH Device Record Key	4c223254-6804-459e-a5ee-596c0d9b420c
Commercial Distribution Status	In Commercial Distribution
Brand Name	One-Piece Introducer Tray
Version Model Number	494435
Catalog Number	494435
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
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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00886333213238 [Primary]
GS1	20886333213232 [Package] Contains: 00886333213238 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	2016-09-21

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