Identity
- Trade Name
- Integrity FDA UDI
- Generic Name
- Bare-metal coronary artery stent FDA UDI
- Device Name
- Stent INT35022W INTEGRITY 3.50X22W FDA UDI
- Model / Reference
- INT35022W FDA UDI
- Description
- Stent INT35022W INTEGRITY 3.50X22W FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00613994602275 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
- Not 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 — 22.0 Millimeter FDA UDI
Integrity by Medtronic, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (1)
- FDA UDI f54554fc-274d-43c7-9ed5-d400c6774943 38 fields · synced Jun 8, 2026