Axcess Percutaneous Catheter Introducer Kit 496036

GUDID 10886333213389

6F Axcess Percutaneous Catheter Introducer Kit

ARGON MEDICAL DEVICES, INC.

Vascular catheter introduction set, nonimplantable
Primary Device ID10886333213389
NIH Device Record Key2e398e6e-52f6-4133-8a7b-1ad50ca5333f
Commercial Distribution StatusIn Commercial Distribution
Brand NameAxcess Percutaneous Catheter Introducer Kit
Version Model Number496036
Catalog Number496036
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
GS100886333213382 [Primary]
GS110886333213389 [Package]
Contains: 00886333213382
Package: Box [10 Units]
In Commercial Distribution
GS120886333213386 [Package]
Contains: 00886333213382
Package: Box [50 Units]
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 [Axcess Percutaneous Catheter Introducer Kit]

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108863332133967F Axcess Percutaneous Catheter Introducer Kit
108863332133896F Axcess Percutaneous Catheter Introducer Kit
108863332133658F Axcess Percutaneous Catheter Introducer Kit
108863332133587F Axcess Percutaneous Catheter Introducer Kit
108863332133416F Axcess Percutaneous Catheter Introducer Kit
108863332133345F Axcess Percutaneous Catheter Introducer Kit
108863332133276F Axcess Percutaneous Catheter Introducer Kit
108863332133039F Axcess Percutaneous Catheter Introducer Kit
108863332132978F Axcess Percutaneous Catheter Introducer Kit
108863332132736F Axcess Percutaneous Catheter Introducer Kit
108863332132665F Axcess Percutaneous Catheter Introducer Kit
108863332132594F Axcess Percutaneous Catheter Introducer Kit

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