XIENCE Skypoint™

Basic Information

• Brand Name: XIENCE Skypoint™
• Primary DI: 08717648233371
• Version / Model: 1804350-08
• Catalog Number: 1804350-08
• Company Name: ABBOTT VASCULAR INC.
• Labeler DUNS: 964569052
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-27
• Public Version: 4
• Public Version Date: 2022-11-08
• Public Version Status: Update
• Public Device Record Key: abdb5154-fb15-495a-a2ac-4264c62cf7a9

Device Description

XIENCE Skypoint™ Everolimus Eluting Coronary Stent System 3.50 mm x 08 mm / Rapid-Exchange

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NIQ	Coronary drug-eluting stent	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
56284	Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated	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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08717648233371	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Stent Length	8	Millimeter
Stent Diameter	3.5	Millimeter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 25 – 25 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Store in a dry, dark, cool place. Protect from light. Do not remove from carton until ready for use. Store at 25°C (77°F); excursions permitted between 15-30°C(59-86°F).