RADIFOCUS GLIDECATH
GLIDECATH - CG515
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
- Fragile. Keep dry. Keep away from sunlight. Stacking limit by 10.
Device Sizes
- Pressure: 6895 KiloPascal
- Max Guide Wire O.D. : .038" (0.97mm)
- Hydrophilic Coating Length : 40cm
- Length: 100 Centimeter
- Outer Diameter: 1.70 Millimeter
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 IdentifiersDevice Id: 34987350772610
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 04987350772619
Package Quantity: 5
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Shelfbox
Device Id: 04987350772619
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
Device Id: 54987350772614
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 34987350772610
Package Quantity: 5
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Carton
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