STENT RONYX20008W RESOLUTE ONYX 2.00X08

STENT RONYX20008W RESOLUTE ONYX 2.00X08
Resolute Onyx™ - RONYX20008W

Device Description

A non-bioabsorbable metal tubular mesh structure covered with a non-bioabsorbable polymer and a drug coating that is designed to be implanted, via a delivery catheter, into a coronary artery (or saphenous vein graft) to maintain its patency typically in a patient with symptomatic atherosclerotic heart disease. The drug coating is slowly released and intended to inhibit restenosis by reducing vessel smooth muscle cell proliferation. Disposable devices associated with implantation may be included.

Environmental Conditions

Special Storage Condition, Specify

Store in the original container. Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F).

Storage Environment Temperature - Degrees Celsius

30.00
15.00

Device Sizes

Stent Inner Diameter 2.0 MM

Length: 8.0 Millimeter

Stent Inner Diameter 2.0 MM
Length: 8.0 Millimeter

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: NIQ

Device Name: Coronary Drug-Eluting Stent

Device Class: 3

Physical State: N/A

Definition: Stent, coronary, drug-eluting -- a metal scaffold with a drug coating placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen. The drug coating is intended to inhibit restenosis.

Submission Type ID: 2

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: Y

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Identifiers

Device Id: 00643169602144

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