FDA UDI
In Commercial Distribution
🇺🇸 United States
Esprit™
DI: 08717648357015
·
Model: 1203300-38
·
ABBOTT VASCULAR INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Esprit™
- Primary DI
- 08717648357015
- Version / Model
- 1203300-38
- Catalog Number
- 1203300-38
- Company Name
- ABBOTT VASCULAR INC.
- Labeler DUNS
- 964569052
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-07
- Public Version
- 6
- Public Version Date
- 2025-11-17
- Public Version Status
- Update
- Public Device Record Key
- ad8e285f-21aa-4d24-976d-4e744a48ec96
Device Description
Esprit™ BTK Everolimus Eluting Resorbable Scaffold System 3.00mm x 38mm Rapid-Exchange
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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 | 08717648357015 | GS1 |
Customer Contacts
- Phone
- +1(800)227-9902
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- 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