Navilyst

GUDID H965960003020

NAVILYST MEDICAL, INC.

Cardiac/peripheral vascular guidewire, single-use
Primary Device IDH965960003020
NIH Device Record Keyc851e9c1-35f1-4d3d-bcf8-fce9d0446a7b
Commercial Distribution StatusIn Commercial Distribution
Brand NameNavilyst
Version Model Number96000302
Company DUNS809699023
Company NameNAVILYST MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(518)795-1676
Emaildgreer@angiodynamics.com

Device Dimensions

Outer Diameter0.035 Inch
Outer Diameter0.035 Inch

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCH965960003020 [Primary]
HIBCCH965960003021 [Package]
Package: Box [5 Units]
In Commercial Distribution

FDA Product Code

DQXWire, guide, catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-04-01
Device Publish Date2019-01-11

On-Brand Devices [Navilyst]

H96596000604096000604
H96596000304096000304
H96596000302096000302
H96596000218096000218
H74990510002090510002
H74990510001090510001
H965457471Vascular Guidewire, Nitinol w/ Hydrophilic Coating, Straight, Radiopaque Tip
H965457461Vascular Guidewire, Nitinol w/ Hydrophilic Coating, Straight, Radiopaque Tip
H965970005051Angiographic Guidewire, Movable Core, J Tip
H965970005041Angiographic Guidewire, Movable Core, J Tip
H965970002331Angiographic Guidewire, Fixed Core, J Tip
H965970002191Angiographic Guidewire, Fixed Core, J Tip
H965970002061Angiographic Guidewire, Fixed Core, J Tip
H965970002031Angiographic Guidewire, Fixed Core, J Tip
H965970001041Angiographic Guidewire, Fixed Core, Straight Tip
H965970001021Angiographic Guidewire, Fixed Core, Straight Tip
H965970006021Angiographic Guidewire, Fixed Core, Straight Tip
H965970005081Angiographic Guidewire, Movable Core, J Tip
H965970005071Angiographic Guidewire, Movable Core, J Tip
H965970005011Angiographic Guidewire, Movable Core, J Tip
H965970004021Angiographic Guidewire, Fixed Core, Straight Tip
H965970004011Angiographic Guidewire, Fixed Core, Straight Tip
H965970003071Angiographic Guidewire, Fixed Core, J Tip
H965970003021Angiographic Guidewire, Fixed Core, J Tip
H965970002351Angiographic Guidewire, Fixed Core, J Tip
H965970002321Angiographic Guidewire, Fixed Core, J Tip
H965970002221Angiographic Guidewire, Fixed Core, J Tip
H965970002161Angiographic Guidewire, Fixed Core, J Tip
H965970002101Angiographic Guidewire, Fixed Core, J Tip
H965970002081Angiographic Guidewire, Fixed Core, J Tip
H965970002021Angiographic Guidewire, Fixed Core, J Tip
H965970002011Angiographic Guidewire, Fixed Core, J Tip
H965970001121Angiographic Guidewire, Fixed Core, Straight Tip
H965970001091Angiographic Guidewire, Fixed Core, Straight Tip
H965970001061Angiographic Guidewire, Fixed Core, Straight Tip
H965970001051Angiographic Guidewire, Fixed Core, Straight Tip
H965970001011Angiographic Guidewire, Fixed Core, Straight Tip
H965960006031Angiographic Guidewire, Fixed Core, Straight Tip
H965960003031Angiographic Guidewire, Fixed Core, J/Straight Tip
H965960002171Angiographic Guidewire, Fixed Core, J Tip

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