- Physicians Office Resource

RADIFOCUS GLIDECATH
GLIDECATH - CG405

Device Description

A thin, flexible tube designed to inject a contrast medium into select blood vessels of the cerebral, visceral, or peripheral vasculature during an angiographic procedure in order to facilitate the clear visualization of the vascular system of a targeted organ or area of the body. It is introduced percutaneously, has a radiopaque marker(s) for positioning, and may include disposable devices dedicated to catheter introduction/function [e.g., sheath(s)]. It may also be used for simultaneous pressure measurements to determine the transvalvular, intravascular, and intraventricular pressure gradients. This is a single-use device.

Environmental Conditions

Special Storage Condition, Specify

Fragile. Keep dry. Keep away from sunlight. Stacking limit by 10.

Device Sizes

Max Guide Wire O.D. : .038" (0.97mm)

Hydrophilic Coating Length : 15cm

Length: 100 Centimeter

Outer Diameter: 1.40 Millimeter

Pressure: 5171 KiloPascal

Max Guide Wire O.D. : .038" (0.97mm)
Hydrophilic Coating Length : 15cm
Length: 100 Centimeter
Outer Diameter: 1.40 Millimeter
Pressure: 5171 KiloPascal

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: DQO

Device Name: Catheter, Intravascular, Diagnostic

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 870.1200

Third Party Flag: Y

Medical Specialty: CV

Device Identifiers

Device Id: 54987350771990

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 34987350771996

Package Quantity: 5

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Carton

Device Id: 34987350771996

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 04987350771995

Package Quantity: 5

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Shelfbox

Device Id: 04987350771995

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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