Identity
- Trade Name
- XIENCE Sierra™ FDA UDI
- Generic Name
- Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated FDA UDI
- Device Name
- XIENCE Sierra™ Everolimus Eluting Coronary Stent System 2.25 mm x 38 mm / Rapid-Exchange FDA UDI
- Model / Reference
- 1550225-38 FDA UDI
- Description
- XIENCE Sierra™ Everolimus Eluting Coronary Stent System 2.25 mm x 38 mm / Rapid-Exchange FDA UDI
Identifiers
- Catalog Number
- 1550225-38 FDA UDI
- Primary DI / UDI-DI
- 08717648227066 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
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Stent Length — 38 Millimeter FDA UDIStent Diameter — 2.25 Millimeter FDA UDI
Category: Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
XIENCE Sierra™ 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.
- SYNERGY™ XD — Boston Scientific · Class III
- SYNERGY™ XD — Boston Scientific · Class III
- Resolute Integrity™ — MEDTRONIC, INC. · Class III
- Resolute Onyx™ — MEDTRONIC, INC. · Class III
- Resolute Integrity™ — MEDTRONIC, INC. · Class III
- Resolute Integrity™ — MEDTRONIC, INC. · Class III
- Resolute Onyx™ — MEDTRONIC, INC. · Class III
- Onyx Frontier™ — MEDTRONIC, INC. · Class III
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Abbott Vascular
Sources (1)
- FDA UDI aa5dc29c-10d5-444e-908f-e993be1a77b0 38 fields · synced Jun 6, 2026