Esprit™

Basic Information

• Brand Name: Esprit™
• Primary DI: 08717648353765
• Version / Model: Esprit™
• Catalog Number: 1212375-28
• Company Name: ABBOTT VASCULAR INC.
• Labeler DUNS: 964569052
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-12
• Public Version: 2
• Public Version Date: 2025-07-24
• Public Version Status: Update
• Public Device Record Key: 408c9854-3b40-4835-99b9-9962534a6d2a

Device Description

Esprit™ BTK Everolimus Eluting Resorbable Scaffold System 3.75mm x 28mm Over-The-Wire

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
NXW	Scaffold, infrapopliteal, absorbable	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
62609	Drug-eluting peripheral artery stent, bioabsorbable	A bioabsorbable polymer tubular mesh structure with a drug coating intended to be implanted in a peripheral artery (excludes aorta, coronary, pulmonary, and intracranial arteries) to maintain luminal patency in patients with symptomatic atherosclerotic disease [e.g., critical limb ischemia (CLI), severe leg claudication]; it is not dedicated to carotid artery implantation, and not intended for connection with an aortic stent. The drug coating is slowly released and intended to inhibit restenosis. Disposable devices associated with implantation may be included with the device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08717648353765	GS1

Customer Contacts

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