XIENCE Skypoint™ 1804500-28

GUDID 08717648233661

XIENCE Skypoint™ Everolimus Eluting Coronary Stent System 5.00 mm x 28 mm / Rapid-Exchange

ABBOTT VASCULAR INC.

Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
Primary Device ID08717648233661
NIH Device Record Key3b814f98-b85d-4390-bd75-101484d08140
Commercial Distribution StatusIn Commercial Distribution
Brand NameXIENCE Skypoint™
Version Model Number1804500-28
Catalog Number1804500-28
Company DUNS964569052
Company NameABBOTT VASCULAR INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)227-9902
Emailav.customercare@av.abbott.com
Phone+1(800)227-9902
Emailav.customercare@av.abbott.com
Phone+1(800)227-9902
Emailav.customercare@av.abbott.com
Phone+1(800)227-9902
Emailav.customercare@av.abbott.com
Phone+1(800)227-9902
Emailav.customercare@av.abbott.com
Phone+1(800)227-9902
Emailav.customercare@av.abbott.com
Phone+1(800)227-9902
Emailav.customercare@av.abbott.com
Phone+1(800)227-9902
Emailav.customercare@av.abbott.com
Phone+1(800)227-9902
Emailav.customercare@av.abbott.com
Phone+1(800)227-9902
Emailav.customercare@av.abbott.com
Phone+1(800)227-9902
Emailav.customercare@av.abbott.com
Phone+1(800)227-9902
Emailav.customercare@av.abbott.com
Phone+1(800)227-9902
Emailav.customercare@av.abbott.com
Phone+1(800)227-9902
Emailav.customercare@av.abbott.com
Phone+1(800)227-9902
Emailav.customercare@av.abbott.com
Phone+1(800)227-9902
Emailav.customercare@av.abbott.com

Device Dimensions

Stent Length28 Millimeter
Stent Diameter5 Millimeter
Stent Length28 Millimeter
Stent Diameter5 Millimeter
Stent Length28 Millimeter
Stent Diameter5 Millimeter
Stent Length28 Millimeter
Stent Diameter5 Millimeter
Stent Length28 Millimeter
Stent Diameter5 Millimeter
Stent Length28 Millimeter
Stent Diameter5 Millimeter
Stent Length28 Millimeter
Stent Diameter5 Millimeter
Stent Length28 Millimeter
Stent Diameter5 Millimeter
Stent Length28 Millimeter
Stent Diameter5 Millimeter
Stent Length28 Millimeter
Stent Diameter5 Millimeter
Stent Length28 Millimeter
Stent Diameter5 Millimeter
Stent Length28 Millimeter
Stent Diameter5 Millimeter
Stent Length28 Millimeter
Stent Diameter5 Millimeter
Stent Length28 Millimeter
Stent Diameter5 Millimeter
Stent Length28 Millimeter
Stent Diameter5 Millimeter
Stent Length28 Millimeter
Stent Diameter5 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *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).
Storage Environment TemperatureBetween 25 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *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).
Storage Environment TemperatureBetween 25 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *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).
Storage Environment TemperatureBetween 25 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *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).
Storage Environment TemperatureBetween 25 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *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).
Storage Environment TemperatureBetween 25 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *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).
Storage Environment TemperatureBetween 25 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *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).
Storage Environment TemperatureBetween 25 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *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).
Storage Environment TemperatureBetween 25 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *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).
Storage Environment TemperatureBetween 25 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *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).
Storage Environment TemperatureBetween 25 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *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).
Storage Environment TemperatureBetween 25 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *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).
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *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).
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *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).
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *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).
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 25 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *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).

Device Identifiers

Device Issuing AgencyDevice ID
GS108717648233661 [Primary]

FDA Product Code

NIQCoronary drug-eluting stent

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-09
Device Publish Date2022-04-29

On-Brand Devices [XIENCE Skypoint™]

08717648233678XIENCE Skypoint™ Everolimus Eluting Coronary Stent System 5.00 mm x 33 mm / Rapid-Exchange
08717648233661XIENCE Skypoint™ Everolimus Eluting Coronary Stent System 5.00 mm x 28 mm / Rapid-Exchange
08717648233654XIENCE Skypoint™ Everolimus Eluting Coronary Stent System 5.00 mm x 23 mm / Rapid-Exchange
08717648233647XIENCE Skypoint™ Everolimus Eluting Coronary Stent System 5.00 mm x 18 mm / Rapid-Exchange
08717648233630XIENCE Skypoint™ Everolimus Eluting Coronary Stent System 5.00 mm x 15 mm / Rapid-Exchange
08717648233623XIENCE Skypoint™ Everolimus Eluting Coronary Stent System 5.00 mm x 12 mm / Rapid-Exchange
08717648233593XIENCE Skypoint™ Everolimus Eluting Coronary Stent System 4.50 mm x 33 mm / Rapid-Exchange
08717648233586XIENCE Skypoint™ Everolimus Eluting Coronary Stent System 4.50 mm x 28 mm / Rapid-Exchange
08717648233579XIENCE Skypoint™ Everolimus Eluting Coronary Stent System 4.50 mm x 23 mm / Rapid-Exchange
08717648233562XIENCE Skypoint™ Everolimus Eluting Coronary Stent System 4.50 mm x 18 mm / Rapid-Exchange
08717648233555XIENCE Skypoint™ Everolimus Eluting Coronary Stent System 4.50 mm x 15 mm / Rapid-Exchange
08717648233548XIENCE Skypoint™ Everolimus Eluting Coronary Stent System 4.50 mm x 12 mm / Rapid-Exchange
08717648231315XIENCE Skypoint™ Everolimus Eluting Coronary Stent System 4.00 mm x 48 mm / Rapid-Exchange
08717648231308XIENCE Skypoint™ Everolimus Eluting Coronary Stent System 3.50 mm x 48 mm / Rapid-Exchange
08717648231285XIENCE Skypoint™ Everolimus Eluting Coronary Stent System 3.00 mm x 48 mm / Rapid-Exchange
08717648231278XIENCE Skypoint™ Everolimus Eluting Coronary Stent System 2.75 mm x 48 mm / Rapid-Exchange
08717648231261XIENCE Skypoint™ Everolimus Eluting Coronary Stent System 2.50 mm x 48 mm / Rapid-Exchange

Trademark Results [XIENCE Skypoint]

Mark Image

Registration | Serial
Company
Trademark
Application Date
XIENCE SKYPOINT
XIENCE SKYPOINT
88421411 not registered Live/Pending
Abbott Cardiovascular Systems Inc.
2019-05-08

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