Identity
- Trade Name
- Integrity FDA UDI
- Generic Name
- Bare-metal coronary artery stent FDA UDI
- Device Name
- Stent INT27518UX INTEGRITY 2.75X18UX FDA UDI
- Model / Reference
- INT27518UX FDA UDI
- Description
- Stent INT27518UX INTEGRITY 2.75X18UX FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00613994798855 FDA UDI
- PMA Number
- P030009 FDA UDI
- FDA Product Code
- MAF FDA UDI
- GMDN Term
- Bare-metal coronary artery stent 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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 18.0 Millimeter FDA UDI
Category: Bare-metal coronary artery stent
Integrity by Medtronic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bare-metal coronary artery stent.
- REBEL™ — Boston Scientific · Class III
- Graftmaster — Abbott Vascular · Unclassified
- Tryton Side Branch Stent — TRYTON MEDICAL, INC. · Class III
- Cobra PzF — Celonova Biosciences, Inc. · Class III
- REBEL™ — Boston Scientific · Class III
- REBEL™ — Boston Scientific · Class III
- REBEL™ — Boston Scientific · Class III
- NIRxcell CoCr Coronary Stent on RX System — MEDINOL LTD. · Class III
Cleared under the same submission
P030009 also covers:
- Integrity — MEDTRONIC, INC.
- Integrity — MEDTRONIC, INC.
- Integrity — MEDTRONIC, INC.
- Integrity — MEDTRONIC, INC.
- Integrity — MEDTRONIC, INC.
- Integrity — MEDTRONIC, INC.
- Integrity — MEDTRONIC, INC.
- Integrity — MEDTRONIC, INC.
- Integrity — MEDTRONIC, INC.
- Integrity — MEDTRONIC, INC.
- Integrity — MEDTRONIC, INC.
- Integrity — MEDTRONIC, INC.
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 |
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Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (1)
- FDA UDI 2d0066d6-ac72-4365-8041-997784d68280 37 fields · synced May 31, 2026