Esprit™ 1203300-38

GUDID 08717648357015

Esprit™ BTK Everolimus Eluting Resorbable Scaffold System 3.00mm x 38mm Rapid-Exchange

ABBOTT VASCULAR INC.

Drug-eluting peripheral artery stent, bioabsorbable

• Primary Device ID: 08717648357015
• NIH Device Record Key: ad8e285f-21aa-4d24-976d-4e744a48ec96
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Esprit™
• Version Model Number: 1203300-38
• Catalog Number: 1203300-38
• 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: true
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Do not separate the product from temperature monitor until ready for use. Store at or below 25°C (77°F); excursions permitted to 30°C (86°F)
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Do not separate the product from temperature monitor until ready for use. Store at or below 25°C (77°F); excursions permitted to 30°C (86°F)
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Do not separate the product from temperature monitor until ready for use. Store at or below 25°C (77°F); excursions permitted to 30°C (86°F)
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Do not separate the product from temperature monitor until ready for use. Store at or below 25°C (77°F); excursions permitted to 30°C (86°F)
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Do not separate the product from temperature monitor until ready for use. Store at or below 25°C (77°F); excursions permitted to 30°C (86°F)
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Do not separate the product from temperature monitor until ready for use. Store at or below 25°C (77°F); excursions permitted to 30°C (86°F)
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Do not separate the product from temperature monitor until ready for use. Store at or below 25°C (77°F); excursions permitted to 30°C (86°F)
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Do not separate the product from temperature monitor until ready for use. Store at or below 25°C (77°F); excursions permitted to 30°C (86°F)
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Do not separate the product from temperature monitor until ready for use. Store at or below 25°C (77°F); excursions permitted to 30°C (86°F)
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Do not separate the product from temperature monitor until ready for use. Store at or below 25°C (77°F); excursions permitted to 30°C (86°F)
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Do not separate the product from temperature monitor until ready for use. Store at or below 25°C (77°F); excursions permitted to 30°C (86°F)
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Do not separate the product from temperature monitor until ready for use. Store at or below 25°C (77°F); excursions permitted to 30°C (86°F)
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Do not separate the product from temperature monitor until ready for use. Store at or below 25°C (77°F); excursions permitted to 30°C (86°F)
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Do not separate the product from temperature monitor until ready for use. Store at or below 25°C (77°F); excursions permitted to 30°C (86°F)
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Do not separate the product from temperature monitor until ready for use. Store at or below 25°C (77°F); excursions permitted to 30°C (86°F)
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Do not separate the product from temperature monitor until ready for use. Store at or below 25°C (77°F); excursions permitted to 30°C (86°F)
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight. Do not separate the product from temperature monitor until ready for use. Store at or below 25°C (77°F); excursions permitted to 30°C (86°F)

Device Identifiers

Device Issuing Agency	Device ID
GS1	08717648357015 [Primary]

FDA Product Code

• NXW: Stent, infrapopliteal, absorbable

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: 2024-05-15
• Device Publish Date: 2024-05-07

On-Brand Devices [Esprit™]

• 08717648357251: Esprit™ BTK Everolimus Eluting Resorbable Scaffold System 2.50mm x 38mm Rapid-Exchange
• 08717648357237: Esprit™ BTK Everolimus Eluting Resorbable Scaffold System 2.50mm x 28mm Rapid-Exchange
• 08717648357213: Esprit™ BTK Everolimus Eluting Resorbable Scaffold System 2.50mm x 18mm Rapid-Exchange
• 08717648357176: Esprit™ BTK Everolimus Eluting Resorbable Scaffold System 3.75mm x 38mm Rapid-Exchange
• 08717648357138: Esprit™ BTK Everolimus Eluting Resorbable Scaffold System 3.75mm x 18mm Rapid-Exchange
• 08717648357091: Esprit™ BTK Everolimus Eluting Resorbable Scaffold System 3.50mm x 38mm Rapid-Exchange
• 08717648357077: Esprit™ BTK Everolimus Eluting Resorbable Scaffold System 3.50mm x 28mm Rapid-Exchange
• 08717648357053: Esprit™ BTK Everolimus Eluting Resorbable Scaffold System 3.50mm x 18mm Rapid-Exchange
• 08717648357015: Esprit™ BTK Everolimus Eluting Resorbable Scaffold System 3.00mm x 38mm Rapid-Exchange
• 08717648356995: Esprit™ BTK Everolimus Eluting Resorbable Scaffold System 3.00mm x 28mm Rapid-Exchange
• 08717648356971: Esprit™ BTK Everolimus Eluting Resorbable Scaffold System 3.00mm x 18mm Rapid-Exchange
• 08717648357152: Esprit™ BTK Everolimus Eluting Resorbable Scaffold System 3.75mm x 28mm Rapid-Exchange