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Cordis S.M.A.R.T. Control Vascular Stent System
FDA UDIClass III (US FDA UDI)
by Cordis Corp.
Identity
- Trade Name
- Cordis S.M.A.R.T. Control Vascular Stent System FDA UDI
- Generic Name
- Peripheral artery stent, bare-metal FDA UDI
- Model / Reference
- C09040ML FDA UDI
Identifiers
- Catalog Number
- C09040ML FDA UDI
- Primary DI / UDI-DI
- 20705032024393 FDA UDI
- FDA Product Code
- NIP FDA UDINIO FDA UDI
- GMDN Term
- Peripheral artery stent, bare-metal 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Peripheral artery stent, bare-metalBare-metal biliary stent
Cordis S.M.A.R.T. Control Vascular Stent System by Cordis Corp. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bare-metal biliary stent.
- ALIMAXX-B® — Merit Medical Systems, Inc. · Class II
- PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System — Cordis US Corp. · Class II
- LifeStar® Biliary Stent — Bard Peripheral Vascular · Class II
- SMART FLEX — Cordis US Corp. · Class II
- BONASTENT® Biliary — Sewoon Medical Co., Ltd. · Class II
- Palmaz BLUE Transhepatic Biliary Stent on SLALOM .018 System — Cordis US Corp. · Class II
- Valeo® Balloon Expandable Biliary Stent — Bard Peripheral Vascular · Class II
- E·Luminexx® Biliary Stent — Bard Peripheral Vascular · Class II
Cleared under the same submission
P020036 also covers:
- Cordis S.M.A.R.T. Control Vascular Stent System — Cordis Corp.
- Cordis S.M.A.R.T. Control Vascular Stent System — Cordis Corp.
- Cordis S.M.A.R.T. Control Vascular Stent System — Cordis Corp.
- S.M.A.R.T. RADIANZ — Cordis Corp.
- S.M.A.R.T. RADIANZ — Cordis Corp.
- S.M.A.R.T. RADIANZ — Cordis Corp.
- S.M.A.R.T. RADIANZ — Cordis Corp.
- Cordis S.M.A.R.T. Control Vascular Stent System — Cordis US Corp.
- Cordis S.M.A.R.T. Control Vascular Stent System — Cordis US Corp.
- Cordis S.M.A.R.T. Control Vascular Stent System — Cordis US Corp.
- Cordis S.M.A.R.T. Control Vascular Stent System — Cordis US Corp.
- Cordis S.M.A.R.T. Control Vascular Stent System — Cordis US Corp.
P120002 also covers:
- Cordis S.M.A.R.T. Control Vascular Stent System — Cordis Corp.
- Cordis S.M.A.R.T. Control Vascular Stent System — Cordis Corp.
- Cordis S.M.A.R.T. Vascular Stent System — Cordis Corp.
- S.M.A.R.T. RADIANZ — Cordis Corp.
- S.M.A.R.T. RADIANZ — Cordis Corp.
- S.M.A.R.T. RADIANZ — Cordis Corp.
- S.M.A.R.T. RADIANZ — Cordis Corp.
- S.M.A.R.T. RADIANZ — Cordis Corp.
- S.M.A.R.T. RADIANZ — Cordis Corp.
- Cordis S.M.A.R.T. Control Vascular Stent System — Cordis US Corp.
- Cordis S.M.A.R.T. Control Vascular Stent System — Cordis US Corp.
- Cordis S.M.A.R.T. Control Vascular Stent System — Cordis US Corp.
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
- Cordis Corp.
Sources (1)
- FDA UDI 4a8bff48-a0e2-4152-98b4-55132d9ed4c6 35 fields · synced Jun 6, 2026