Primary Device ID | 08717648231278 |
NIH Device Record Key | 201fad36-a7aa-4e80-80cd-e11809b730b7 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | XIENCE Skypoint™ |
Version Model Number | 1804275-48 |
Catalog Number | 1804275-48 |
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 |
Stent Length | 48 Millimeter |
Stent Diameter | 2.75 Millimeter |
Stent Length | 48 Millimeter |
Stent Diameter | 2.75 Millimeter |
Stent Length | 48 Millimeter |
Stent Diameter | 2.75 Millimeter |
Stent Length | 48 Millimeter |
Stent Diameter | 2.75 Millimeter |
Stent Length | 48 Millimeter |
Stent Diameter | 2.75 Millimeter |
Stent Length | 48 Millimeter |
Stent Diameter | 2.75 Millimeter |
Stent Length | 48 Millimeter |
Stent Diameter | 2.75 Millimeter |
Stent Length | 48 Millimeter |
Stent Diameter | 2.75 Millimeter |
Stent Length | 48 Millimeter |
Stent Diameter | 2.75 Millimeter |
Stent Length | 48 Millimeter |
Stent Diameter | 2.75 Millimeter |
Stent Length | 48 Millimeter |
Stent Diameter | 2.75 Millimeter |
Stent Length | 48 Millimeter |
Stent Diameter | 2.75 Millimeter |
Stent Length | 48 Millimeter |
Stent Diameter | 2.75 Millimeter |
Stent Length | 48 Millimeter |
Stent Diameter | 2.75 Millimeter |
Stent Length | 48 Millimeter |
Stent Diameter | 2.75 Millimeter |
Stent Length | 48 Millimeter |
Stent Diameter | 2.75 Millimeter |
Stent Length | 48 Millimeter |
Stent Diameter | 2.75 Millimeter |
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 Issuing Agency | Device ID |
---|---|
GS1 | 08717648231278 [Primary] |
NIQ | Coronary drug-eluting stent |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-12-25 |
Device Publish Date | 2023-12-15 |
08717648233678 | XIENCE Skypoint™ Everolimus Eluting Coronary Stent System 5.00 mm x 33 mm / Rapid-Exchange |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
XIENCE SKYPOINT 88421411 not registered Live/Pending |
Abbott Cardiovascular Systems Inc. 2019-05-08 |