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Xience Alpine

FDA UDI

Class III (US FDA UDI)

by Abbott Vascular

Identity

Trade Name
XIENCE ALPINE FDA UDI
Generic Name
Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated FDA UDI
Device Name
XIENCE Alpine Everolimus Eluting Coronary Stent System 3.00 mm x 08 mm / Over-The-Wire FDA UDI
Model / Reference
1145300-08 FDA UDI
Description
XIENCE Alpine Everolimus Eluting Coronary Stent System 3.00 mm x 08 mm / Over-The-Wire FDA UDI

Identifiers

Catalog Number
1145300-08 FDA UDI
Primary DI / UDI-DI
08717648200045 FDA UDI
FDA Product Code
NIQ FDA UDI
GMDN Term
Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated

Xience Alpine by Abbott Vascular — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abbott Vascular

Sources (1)

  • FDA UDI 81181fb7-30db-4dbe-a4fe-6b55b95bba86 36 fields · synced May 31, 2026