AccessGUDID - DEVICE: Esprit™ (08717648356995)

GUDID

Device Identifier (DI) Information

Brand Name: Esprit™
Version or Model: 1203300-28
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1203300-28
Company Name: ABBOTT VASCULAR INC.

Primary DI Number: 08717648356995
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 964569052 *Terms of Use

Device Description: Esprit™ BTK Everolimus Eluting Resorbable Scaffold System 3.00mm x 28mm Rapid-Exchange

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NXW	Scaffold, Infrapopliteal, Absorbable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep dry and away from sunlight. Store at or below 25°C (77°F); temporary excursions up to 30°C (86°F) are permissible if the temperature monitor confirms suitability. Check monitor before use

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e3ff53b4-0e87-4312-9d7c-08a9bbde78aa
Public Version Date: May 28, 2025
Public Version Number: 4
DI Record Publish Date: May 07, 2024