Axcess Percutaneous Introducer 191745

GUDID 20886333206920

Axcess Percutaneous Introducer with Multi-Purpose Curve 7F x 45cm

ARGON MEDICAL DEVICES, INC.

Vascular catheter introduction set, nonimplantable
Primary Device ID20886333206920
NIH Device Record Key6e68f6b7-a055-4b2a-964d-a6319c90130b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAxcess Percutaneous Introducer
Version Model Number191745
Catalog Number191745
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
GS100886333206926 [Primary]
GS120886333206920 [Package]
Contains: 00886333206926
Package: Box [10 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 Date2016-09-12

On-Brand Devices [Axcess Percutaneous Introducer]

20886333206951Axcess Percutaneous Introducer with Multi-Purpose Curve 8F x 98cm
20886333206944Axcess Percutaneous Introducer with Multi-Purpose Curve 8F x 45cm
20886333206937Axcess Percutaneous Introducer with Multi-Purpose Curve 7F x 98cm
20886333206920Axcess Percutaneous Introducer with Multi-Purpose Curve 7F x 45cm
20886333206913Axcess Percutaneous Introducer with Multi-Purpose Curve 6F x 98cm
20886333206906Axcess Percutaneous Introducer with Multi-Purpose Curve 6F x 45cm
20886333206890Axcess Percutaneous Introducer with Multi-Purpose Curve 5F x 45cm

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