XIENCE Skypoint™ 1804250-48

GUDID 08717648231261

XIENCE Skypoint™ Everolimus Eluting Coronary Stent System 2.50 mm x 48 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 Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated

• Primary Device ID: 08717648231261
• NIH Device Record Key: 756a729c-b55e-4842-b87f-050d61325086
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XIENCE Skypoint™
• Version Model Number: 1804250-48
• Catalog Number: 1804250-48
• Company DUNS: 964569052
• Company Name: ABBOTT VASCULAR INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Stent Length: 48 Millimeter
• Stent Diameter: 2.5 Millimeter
• Stent Length: 48 Millimeter
• Stent Diameter: 2.5 Millimeter
• Stent Length: 48 Millimeter
• Stent Diameter: 2.5 Millimeter
• Stent Length: 48 Millimeter
• Stent Diameter: 2.5 Millimeter
• Stent Length: 48 Millimeter
• Stent Diameter: 2.5 Millimeter
• Stent Length: 48 Millimeter
• Stent Diameter: 2.5 Millimeter
• Stent Length: 48 Millimeter
• Stent Diameter: 2.5 Millimeter
• Stent Length: 48 Millimeter
• Stent Diameter: 2.5 Millimeter
• Stent Length: 48 Millimeter
• Stent Diameter: 2.5 Millimeter
• Stent Length: 48 Millimeter
• Stent Diameter: 2.5 Millimeter
• Stent Length: 48 Millimeter
• Stent Diameter: 2.5 Millimeter
• Stent Length: 48 Millimeter
• Stent Diameter: 2.5 Millimeter
• Stent Length: 48 Millimeter
• Stent Diameter: 2.5 Millimeter
• Stent Length: 48 Millimeter
• Stent Diameter: 2.5 Millimeter
• Stent Length: 48 Millimeter
• Stent Diameter: 2.5 Millimeter
• Stent Length: 48 Millimeter
• Stent Diameter: 2.5 Millimeter
• Stent Length: 48 Millimeter
• Stent Diameter: 2.5 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 25 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 25 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 25 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 25 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 25 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 25 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 25 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 25 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 25 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 25 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 25 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 25 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 25 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 25 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 25 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 25 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Temperature: Between 25 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 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 Agency	Device ID
GS1	08717648231261 [Primary]

FDA Product Code

• NIQ: Coronary drug-eluting stent

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-25
• Device Publish Date: 2023-12-15

On-Brand Devices [XIENCE Skypoint™]

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