One Step Micro-Introducer System 497863

GUDID 10886333215321

One Step Micro-Introducer System 7F

ARGON MEDICAL DEVICES, INC.

Vascular catheter introduction set, nonimplantable
Primary Device ID10886333215321
NIH Device Record Keyd760d846-212d-42a5-a39d-ea97fedcc21c
Commercial Distribution Discontinuation2017-06-27
Commercial Distribution StatusNot in Commercial Distribution
Brand NameOne Step Micro-Introducer System
Version Model Number497863
Catalog Number497863
Company DUNS140727624
Company NameARGON MEDICAL DEVICES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com
Phone1.800.927.4669
EmailCustomer.Service@argonmedical.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100886333215324 [Primary]
GS110886333215321 [Package]
Contains: 00886333215324
Package: Box [10 Units]
Discontinued: 2017-06-27
Not in Commercial Distribution
GS120886333215328 [Package]
Contains: 00886333215324
Package: Box [50 Units]
Discontinued: 2017-06-27
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DREDilator, Vessel, For Percutaneous Catheterization

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-06-07
Device Publish Date2016-09-09

On-Brand Devices [One Step Micro-Introducer System]

10886333215376One Step Micro-Introducer System 4F
10886333215369One Step Micro-Introducer System 7F
10886333215352One Step Micro-Introducer System 6F
10886333215345One Step Micro-Introducer System 5F
10886333215321One Step Micro-Introducer System 7F
10886333215314One Step Micro-Introducer System 8F
10886333215307One Step Micro-Introducer System 7F
10886333215291One Step Micro-Introducer System 7F
10886333215284One Step Micro-Introducer System 5F
10886333215277One Step Micro-Introducer System 4F
10886333215260One Step Micro-Introducer System 4F
10886333215253One Step Micro-Introducer System 6F
10886333215246One Step Micro-Introducer System 6F
10886333215239One Step Micro-Introducer System 6F
10886333215222One Step Micro-Introducer System 6F
10886333215215One Step Micro-Introducer System 8F
10886333215192One Step Micro-Introducer System 6F
10886333215178One Step Micro-Introducer System 7F
10886333215154One Step Micro-Introducer System 6F
10886333215147One Step Micro-Introducer System 6F
10886333215130One Step Micro-Introducer System 6F
10886333215123One Step Micro-Introducer System 5F
10886333215116One Step Micro-Introducer System 5F
10886333215093One Step Micro-Introducer System 4F

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