FDA.reportPublic FDA data

Esprit™

Primary DI
08717648357251
Brand
Esprit™
Company
ABBOTT VASCULAR INC.
Model
1203250-38
Catalog number
1203250-38
Device description
Esprit™ BTK Everolimus Eluting Resorbable Scaffold System 2.50mm x 38mm Rapid-Exchange
Published
2024-05-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NXWStent, infrapopliteal, absorbable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NXWScaffold, Infrapopliteal, AbsorbableUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08717648357251PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717648357251087176483572518717648357251

GMDN Terms#

Term, Definition table
TermDefinition
Drug-eluting peripheral artery stent, bioabsorbableA bioabsorbable polymer tubular mesh structure with a drug coating intended to be implanted in a peripheral artery (excludes aorta, coronary, 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. The drug coating is slowly released and intended to inhibit restenosis. Disposable devices associated with implantation may be included with the device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep 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.
Special Storage Condition, Specify00Keep 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)

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)227-9902john3103@gmail.com
+1(800)227-9902av.customercare@av.abbott.com

Regulatory Flags#

DUNS number
964569052
Device count
1
Combination product
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08717648175060StarClose SE™ 14679-0514679-052014-11-21
08717648000621Prostar™ 12322-0112322-012014-11-21
08717648199059XIENCE ALPINE1125225-081125225-082014-11-21
08717648199066XIENCE ALPINE1125225-121125225-122014-11-21
08717648199073XIENCE ALPINE1125225-151125225-152014-11-21
08717648199080XIENCE ALPINE1125225-181125225-182014-11-21
08717648199097XIENCE ALPINE1125225-231125225-232014-11-21
08717648199103XIENCE ALPINE1125225-281125225-282014-11-21
08717648199141XIENCE ALPINE1125250-081125250-082014-11-21
08717648199158XIENCE ALPINE1125250-121125250-122014-11-21
08717648199165XIENCE ALPINE1125250-151125250-152014-11-21
08717648199172XIENCE ALPINE1125250-181125250-182014-11-21
08717648199189XIENCE ALPINE1125250-231125250-232014-11-21
08717648199196XIENCE ALPINE1125250-281125250-282014-11-21
08717648199202XIENCE ALPINE1125250-331125250-332014-11-21
08717648199219XIENCE ALPINE1125250-381125250-382014-11-21
08717648199233XIENCE ALPINE1125275-081125275-082014-11-21
08717648199240XIENCE ALPINE1125275-121125275-122014-11-21
08717648199257XIENCE ALPINE1125275-151125275-152014-11-21
08717648199264XIENCE ALPINE1125275-181125275-182014-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08717648353765Esprit™ABBOTT VASCULAR INC.NXW2025-07-12
08717648353666Esprit™ABBOTT VASCULAR INC.NXW2025-07-10
08717648353680Esprit™ABBOTT VASCULAR INC.NXW2025-07-10
08717648353703Esprit™ABBOTT VASCULAR INC.NXW2025-07-10
08717648353741Esprit™ABBOTT VASCULAR INC.NXW2025-07-10
08717648353789Esprit™ABBOTT VASCULAR INC.NXW2025-07-10
08717648353826Esprit™ABBOTT VASCULAR INC.NXW2025-07-10
08717648353840Esprit™ABBOTT VASCULAR INC.NXW2025-07-10
08717648353864Esprit™ABBOTT VASCULAR INC.NXW2025-07-10
08717648353987Esprit™ABBOTT VASCULAR INC.NXW2025-07-10
08717648354007Esprit™ABBOTT VASCULAR INC.NXW2025-07-10
08717648354021Esprit™ABBOTT VASCULAR INC.NXW2025-07-10
08717648357152Esprit™ABBOTT VASCULAR INC.NXW2024-05-09
08717648356971Esprit™ABBOTT VASCULAR INC.NXW2024-05-07
08717648356995Esprit™ABBOTT VASCULAR INC.NXW2024-05-07
08717648357015Esprit™ABBOTT VASCULAR INC.NXW2024-05-07
08717648357053Esprit™ABBOTT VASCULAR INC.NXW2024-05-07
08717648357077Esprit™ABBOTT VASCULAR INC.NXW2024-05-07
08717648357091Esprit™ABBOTT VASCULAR INC.NXW2024-05-07
08717648357138Esprit™ABBOTT VASCULAR INC.NXW2024-05-07
08717648357176Esprit™ABBOTT VASCULAR INC.NXW2024-05-07
08717648357213Esprit™ABBOTT VASCULAR INC.NXW2024-05-07
08717648357237Esprit™ABBOTT VASCULAR INC.NXW2024-05-07