Product Labeling
Instructions For Use (IFU)
Cordis is in the process of upgrading its Product Labeling website for accessing our product's Instructions For Use (IFUs).
During this time, specific information for IFUs is presented below.
North American electronic Instructions For Use (eIFUs)
Selected North American (United States & Canada) product eIFUs are available in the following table.
Product Name | Product Codes | Safety Update | eIFU |
ANGIOGUARD RX Emboli Capture Guidewire System (For Carotid Use) | 401814RMC, 501814REC, 501814RMC, 601814REC, 601814RMC, 701814REC, 701814RMC, 801814REC, 801814RMC | No | |
ANGIOGUARD XP Emboli Capture Guidewire System (For Carotid Use) | 403014EC, 403014MC, 503014EC, 503014MC, 603014EC, 603014MC, 703014EC, 703014MC, 803014EC, 803014MC | No | |
S.M.A.R.T. CONTROL Vascular Stent System (Iliac Indication) | C06020ML, C06020SL, C06030ML, C06030SL, C06040ML, C06040SL, C06060ML, C06060SL, C06080ML, C06080SL, C06100ML, C06100SL, C07020ML, C07020SL, C07030ML, C07030SL, C07040ML, C07040SL, C07060ML, C07060SL, C07080ML, C07080SL, C07100ML, C07100SL, C08020ML, C08020SL, C08030ML, C08030SL, C08040ML, C08040SL, C08060ML, C08060SL, C08080ML, C08080SL, C08100ML, C08100SL, C09020ML, C09020SL, C09030ML, C09030SL, C09040ML, C09040SL, C09060ML, C09060SL, C10020ML, C10020SL, C10030ML, C10030SL, C10040ML, C10040SL, C10060ML, C10060SL | No | |
S.M.A.R.T. CONTROL Vascular Stent System (SFA Indication) | C06120ML, C06150ML, C07120ML, C07150ML, C08120ML, C08150ML | No | |
S.M.A.R.T. RADIANZ Vascular Stent System | 48002002S, 48002002X, 48002003S, 48002003X, 48002004S, 48002004X, 48002006S, 48002006X, 48002008S, 48002008X, 48002010S, 48002010X, 48002015S, 48002015X, 48002020S, 48002020X, 48002025S, 48002025X, 48002030S, 48002030X, 48002502S, 48002502X, 48002503S, 48002503X, 48002504S, 48002504X, 48002506S, 48002506X, 48002508S, 48002508X, 48002510S, 48002510X, 48002515S, 48002515X, 48002520S, 48002520X, 48002525S, 48002525X, 48002530S, 48002530X, 48003002S, 48003002X, 48003003S, 48003003X, 48003004S, 48003004X, 48003006S, 48003006X, 48003008S, 48003008X, 48003010S, 48003010X, 48003015S, 48003015X, 48003020S, 48003020X, 48003025S, 48003025X, 48003030S, 48003030X, 48003502S, 48003502X, 48003503S, 48003503X, 48003504S, 48003504X, 48003506S, 48003506X, 48003508S, 48003508X, 48003510S, 48003510X, 48003515S, 48003515X, 48003520S, 48003520X, 48003525S, 48003525X, 48003530S, 48003530X, 48004002S, 48004002X, 48004003S, 48004003X, 48004004S, 48004004X, 48004006S, 48004006X, 48004008S, 48004008X, 48004010S, 48004010X, 48004015S, 48004015X, 48004020S, 48004020X, 48004025S, 48004025X, 48004030S, 48004030X, 48005002S, 48005002X, 48005003S, 48005003X, 48005004S, 48005004X, 48005006S, 48005006X, 48005008S, 48005008X, 48005010S, 48005010X, 48005015S, 48005015X, 48005020S, 48005020X, 48005025S, 48005025X, 48005030S, 48005030X, 48006002S, 48006002X, 48006003S, 48006003X, 48006004S, 48006004X, 48006006S, 48006006X, 48006008S, 48006008X, 48006010S, 48006010X, 48006015S, 48006015X, 48006020S, 48006020X, 48006025S, 48006025X, 48006030S, 48006030X, 48007002S, 48007002X, 48007003S, 48007003X, 48007004S, 48007004X, 48007006S, 48007006X, 48007008S, 48007008X, 48007010S, 48007010X, 48008002S, 48008002X, 48008003S, 48008003X, 48008004S, 48008004X, 48008006S, 48008006X, 48008008S, 48008008X, 48008010S, 48008010X, 48009002S, 48009002X, 48009003S, 48009003X, 48009004S, 48009004X, 48009006S, 48009006X, 48009008S, 48009008X, 48009010S, 48009010X, 48010002S, 48010002X, 48010003S, 48010003X, 48010004S, 48010004X, 48010006S, 48010006X, 48010008S, 48010008X, 48010010S, 48010010X | No | |
INFINITI Ambi Angiographic Catheter | 555500J352, 555525J352, 555500J402, 555525J402, 555500T401, 555525T401, 555500T451, 555525T451, 555600J352, 555625J352, 555600J402, 555625J402, 555600T401, 555625T401, 555600T451, 555625T451 | No | |
PALMAZ MULLINS XD™ Pulmonary Stent System | PM1910PXD, PM2510PXD, PM2910PXD, PM3910PXD, PM5910PXD | No | eIFU_100574015_R03 |