No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 10884521063150 | 3948L | 3948L | Loading Unit | GDW | STAPLE, IMPLANTABLE | 2 | ILA |
2 | 07290101366256 | FGS-0584 | UGI capsule, 1-pack | NEZ | SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE | 2 | Pillcam | |
3 | 00821684046548 | AB18W020200150 | .018 | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | PowerCross | |
4 | 00821684046487 | AB18W060150090 | .018 | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | PowerCross | |
5 | 00821684046456 | AB18W060080090 | .018 | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | PowerCross | |
6 | 00821684046104 | AB18W020100090 | .018 | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | PowerCross | |
7 | 00821684038604 | SECX-7-40-135 | Carotid Stent System | NIM | STENT, CAROTID | 3 | Protege RX | |
8 | 00821684038598 | SECX-6-40-135 | Carotid Stent System | NIM | STENT, CAROTID | 3 | Protege RX | |
9 | 00821684038550 | SECX-7-30-135 | Carotid Stent System | NIM | STENT, CAROTID | 3 | Protege RX | |
10 | 00884521100636 | 88864490-51 | Monofilament Polybutester | GAT | SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE | 2 | Novafil | |
11 | 00884521080082 | SN-693 | Monofilament Nylon | GAR | SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE | 2 | Monosof | |
12 | 00821684046784 | AB18W050060150 | .018 | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | PowerCross | |
13 | 00821684058381 | N353001 | GW N353001 NITREX V03 | DQX | WIRE, GUIDE, CATHETER | NITREX™ | ||
14 | 00821684046760 | AB18W050020150 | .018 | LIT | Catheter, angioplasty, peripheral, transluminal | 2 | PowerCross | |
15 | 00821684058596 | WWTD35001 | GW WWTD35001 WHOLEY WIRE V02 | DQX | Wire, guide, catheter | Kendall™ | ||
16 | 00821684058060 | MVA200 | ACCESSORY MVA200 Y-CONNECTORS V03 | DYB | INTRODUCER, CATHETER | The Sequel™ | ||
17 | 00821684051658 | EVD35-07-020-150 | STENT EVD35-07-020-150 EF ENTRUST V01 | NIP | STENT, SUPERFICIAL FEMORAL ARTERY | 3 | EverFlex™ | |
18 | 00821684004029 | GN1000 | Snare Kit | DXE | CATHETER, EMBOLECTOMY | 2 | AMPLATZ GOOSE NECK | |
19 | 80884522004090 | 85865 | Intubating Stylet | BSR | STYLET, TRACHEAL TUBE | Mallinckrodt | ||
20 | 50884522007106 | 8LGT | Laryngectomy Tube | JOH | Tube tracheostomy and tube cuff | 2 | Shiley | |
21 | 40884522043831 | 86057 | Lo-Pro Oral/Nasal Tracheal Tube Cuffed,Murphy Eye | BTR | Tube, tracheal (w/wo connector) | Shiley | ||
22 | 40884522007734 | SSVO | Speaking Valve,O2 Port | BTO | Tube, tracheostomy (w/wo connector) | Shiley | ||
23 | 30884521215430 | UNVCA5LGF | Universal Fixation Cannula | GCJ | Laparoscope, General & Plastic Surgery | 2 | VersaOne | |
24 | 20884522040072 | MAXAI | Adult SpO2 Sensor | DQA | Oximeter | 2 | Nellcor | |
25 | 20884521779621 | 4.5NEF | Neonatal Tracheostomy Tube Cuffless | JOH | Tube tracheostomy and tube cuff | 2 | Shiley | |
26 | 20884521149592 | SV-487G | Braided Fast Absorbable Suture,PC-11,1X Undyed Strand | GAM | SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID | 2 | Velosorb Fast | |
27 | 20884521134505 | 186-0106-PH | Quatro Sensor | OLW | Index-generating electroencephalograph software | BIS | ||
28 | 20884521128979 | 170043 | Polyester Triple Stitch Reload | OCW | Endoscopic tissue approximation device | 2 | Surgidac | |
29 | 20884521083919 | PEDICAP | Pediatric Colorimetric CO2 Detector | CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE | Nellcor | ||
30 | 10884524001425 | SEA3700 | ULPA Filter | FYD | APPARATUS, EXHAUST, SURGICAL | 2 | RapidVac | |
31 | 10884524002958 | SCT12 | Torque Wrench | LFL | Instrument, ultrasonic surgical | U | Sonicision | |
32 | 10884524000527 | E2515HDB | Rocker Switch Pencil Holster | GEI | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 2 | Valleylab | |
33 | 10884523002829 | 030451 | Universal Articulating Loading Unit | GDW | STAPLE, IMPLANTABLE | 2 | Endo GIA | |
34 | 10884522030106 | 6.5 PDL | Pediatric Tracheostomy Tube Long Cuffless | JOH | Tube tracheostomy and tube cuff | 2 | Shiley | |
35 | 10884522002066 | 86398 | Laser Oral Tracheal Tube Dual Cuffed Murphy Eye | BTR | Tube, tracheal (w/wo connector) | 2 | Shiley | |
36 | 10884521762589 | VLOCN2147 | Absorbable Wound Closure Device | GAM | SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID | 2 | Syneture | |
37 | 10884521751354 | SSV | Speaking Valve | BTO | Tube, tracheostomy (w/wo connector) | Shiley | ||
38 | 10884521726314 | 9CN90ER | Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula | JOH | Tube tracheostomy and tube cuff | 2 | Shiley | |
39 | 10884521707108 | US1724 | US1724 | Custom Suture Pack | OVN | Suture kit | 2 | Syneture |
40 | 10884521706385 | VLFT10ADP1 | Bipolar Adapter | GEI | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 2 | Valleylab FT10 | |
41 | 10884521592841 | SCDA39 | Curved Jaw Cordless Ultrasonic Dissector | LFL | Instrument, ultrasonic surgical | U | Sonicision | |
42 | 10884521582811 | DLN600X-A | N-600x Pulse Oximeter Alarm Management System | DQA | Oximeter | 2 | Nellcor | |
43 | 10884521546899 | NONB12STS | Bladeless Trocar with Smooth Cannula | GCJ | Laparoscope, general & plastic surgery | 2 | VersaOne | |
44 | 10884521543782 | SIGPHANDLE | Power Handle | GDW | STAPLE, IMPLANTABLE | 2 | Signia | |
45 | 10884521543508 | SIGLU60A | Loading Unit | GDW | STAPLE, IMPLANTABLE | 2 | Signia | |
46 | 10884521199521 | SD301BA | Bronchoscope Adapter;For use with Pentax bronchoscopes | JAK | System, x-ray, tomography, computed | 2 | Edge | |
47 | 10884521196247 | XX-5012 | Uncoated Braided Polyester | GAT | SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE | 2 | Surgidac | |
48 | 10884521195462 | X-1355 | Monofilament Absorbable Suture | GAM | SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID | 2 | Maxon | |
49 | 10884521176621 | TTS-1100 | Channel RFA Endoscopic Catheter,Esophageal TTS, 120 Applications | GEI | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 2 | Barrx | |
50 | 10884521174863 | US1645 | Custom Suture Pack | OVN | Suture kit | 2 | Syneture |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00851354004233 | O250 | O250 | The Ocelot System is intended to facilitate the intraluminal placement of conven The Ocelot System is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen and wall structures. The Ocelot System is contraindicated for use in the iliac, coronary, cerebral, renal or carotid vasculature. | Ocelot IV | AVINGER, INC. |
2 | 00851354004141 | P135 | P135 | "The Ocelot PIXL System consists of the Ocelot PIXL Catheter (“Ocelot PIXL”), th "The Ocelot PIXL System consists of the Ocelot PIXL Catheter (“Ocelot PIXL”), the Lightbox console (“Lightbox”), and the Lightbox Umbilical (“Umbilical”). This system combines the use of Avinger’s peripheral catheter designs and an Optical Coherence Tomography (OCT) intravascular orientation and imaging tool. The Ocelot PIXL System is intended to cross chronic total occlusions in the peripheral vasculature while simultaneously providing OCT visualization to help orient the distal tip of the Ocelot PIXL to support the primary intended use. Use of Ocelot PIXL in conjunction with Lightbox allows for OCT imaging as an adjunct to fluoroscopy which facilitates intravascular orientation of the catheter. See Lightbox Operator’s Manual and Umbilical IFU for guidance on setting up and using the Lightbox and Umbilical, respectively. Ocelot PIXL is available in 2 different lengths, 135cm working length and 150cm working length.Ocelot PIXL is an over-the-wire device compatible with a 5F sheath and 0.014” guidewire. It consists of a catheter shaft with handle assembly at the proximal end and a distal tip designed to cross CTOs. A locking luer connecter at the proximal end provides entry to a lumen that supports and facilitates movement of a guidewire (i.e., Lumen Flush Port). The catheter is sterilized by ethylene oxide and is intended for single use only. " | Ocelot PIXL | AVINGER, INC. |
3 | 00851354004127 | U100 | U100 | Lightbox Umbilical is intended for use in peripheral vascular procedures in conj Lightbox Umbilical is intended for use in peripheral vascular procedures in conjunction with a compatible Avinger product. | Lightbox Umbilical | AVINGER, INC. |
4 | 00845225002565 | PPLUS120 | Pioneer Plus Catheter | PHILIPS IMAGE GUIDED THERAPY CORPORATION | ||
5 | 00842362100031 | 101 | Percutaneous Catheter | DABRA 101 Catheter | RA MEDICAL SYSTEMS, INC. | |
6 | 00842362100024 | RA-308 | A mains electricity (AC-powered) Light Amplification by Stimulated Emission of R A mains electricity (AC-powered) Light Amplification by Stimulated Emission of Radiation (LASER) device assembly in which input energy is used to excite dimers (typically rare gas monohalides such as argon fluoride, xenon chloride) as the active medium to emit a beam of intense, coherent, monochromatic electromagnetic (EM) radiation (UVA and/or UVB) for endovascular therapy. It typically includes a light source, delivery catheter, and controls/foot-switch. It is typically intended to treat endovascular disease. | DABRA Laser System | RA MEDICAL SYSTEMS, INC. | |
7 | 00827002507937 | G50793 | CMW-14-300-25G | Approach, CTO-25 Micro Wire Guide | Approach | COOK INCORPORATED |
8 | 00827002507920 | G50792 | CMW-14-300-18G | Approach, CTO-18 Micro Wire Guide | Approach | COOK INCORPORATED |
9 | 00827002507913 | G50791 | CMW-14-300-12G | Approach, CTO-12 Micro Wire Guide | Approach | COOK INCORPORATED |
10 | 00827002507906 | G50790 | CMW-14-300-6G | Approach, CTO-6 Micro Wire Guide | Approach | COOK INCORPORATED |
11 | 00827002507890 | G50789 | CMW-14-190-25G | Approach, CTO-25 Micro Wire Guide | Approach | COOK INCORPORATED |
12 | 00827002507883 | G50788 | CMW-14-190-18G | Approach, CTO-18 Micro Wire Guide | Approach | COOK INCORPORATED |
13 | 00827002507876 | G50787 | CMW-14-190-12G | Approach, CTO-12 Micro Wire Guide | Approach | COOK INCORPORATED |
14 | 00827002507869 | G50786 | CMW-14-190-6G | Approach, CTO-6 Micro Wire Guide | Approach | COOK INCORPORATED |
15 | 00827002507852 | G50785 | CMW-14-135-25G | Approach, CTO-25 Micro Wire Guide | Approach | COOK INCORPORATED |
16 | 00827002507845 | G50784 | CMW-14-135-18G | Approach, CTO-18 Micro Wire Guide | Approach | COOK INCORPORATED |
17 | 00827002507838 | G50783 | CMW-14-135-12G | Approach, CTO-12 Micro Wire Guide | Approach | COOK INCORPORATED |
18 | 00827002507821 | G50782 | CMW-14-135-6G | Approach, CTO-6 Micro Wire Guide | Approach | COOK INCORPORATED |
19 | 00821684073841 | ENW-SF-014-300 | GW ENW-SF-014-300 CTO RE-ENTRY V03 | Enteer™ | COVIDIEN LP | |
20 | 00821684073834 | ENW-SD-014-300 | GW ENW-SD-014-300 CTO RE-ENTRY V03 | Enteer™ | COVIDIEN LP | |
21 | 00821684073827 | ENW-FX-014-300 | GW ENW-FX-014-300 CTO RE-ENTRY V03 | Enteer™ | COVIDIEN LP | |
22 | 00821684073797 | ENB-375-20-135 | CATH ENB-375-20-135 CTO RE-ENTRY V03 | Enteer™ | COVIDIEN LP | |
23 | 00821684073780 | ENB-275-20-150 | CATH ENB-275-20-150 CTO RE-ENTRY V03 | Enteer™ | COVIDIEN LP | |
24 | 00821684073759 | VNC-SD-150 | CATH VNC-SD-150 CTO CROSSING V05 | Viance™ | COVIDIEN LP | |
25 | 00821684073742 | VNC-FX-150 | CATH VNC-FX-150 CTO CROSSING V05 | Viance™ | COVIDIEN LP | |
26 | 00813132020286 | 518-063AA | 518-063 | Turbo-Booster™ Laser Guide Catheter | Turbo-Booster™ | SPECTRANETICS CORPORATION |
27 | 00813132020279 | 518-043AA | 518-043 | Turbo-Booster™ Laser Guide Catheter | Turbo-Booster™ | SPECTRANETICS CORPORATION |
28 | 00801741202452 | BDRECANSYSTEMS | BDRECANSYSTEMS | Recanalization System, Serviced | Recanalization System | BARD PERIPHERAL VASCULAR, INC. |
29 | 00801741202445 | BDRECANSYSTEML | BDRECANSYSTEML | Recanalization System, Loaner | Recanalization System | BARD PERIPHERAL VASCULAR, INC. |
30 | 00801741202438 | BDRECANSYSTEMR | BDRECANSYSTEMR | Recanalization System, Refurbished | Recanalization System | BARD PERIPHERAL VASCULAR, INC. |
31 | 00801741202421 | BDRECANSYSTEM | BDRECANSYSTEM | Recanalization System | Recanalization System | BARD PERIPHERAL VASCULAR, INC. |
32 | 00801741202414 | BDRECANFOOT | BDRECANFOOT | Recanalization System Footswitch | Recanalization System | BARD PERIPHERAL VASCULAR, INC. |
33 | 00801741201332 | XCTO146 | XCTO146 | Crosser iQ Ultrasonic CTO Device | Crosser iQ | BARD PERIPHERAL VASCULAR, INC. |
34 | 00801741067617 | GEN200 | GEN200 | CROSSER® Generator | CROSSER® | BARD PERIPHERAL VASCULAR, INC. |
35 | 00801741067471 | CRPEDAL | CRPEDAL | CROSSER® System Foot Switch | CROSSER® | BARD PERIPHERAL VASCULAR, INC. |
36 | 00685447001089 | EWK35-250-12-6A-20-05 | PowerWire RF GuideWire; RFP-100A Connector Cable | PowerWire Radiofrequency GuideWire Kit | BAYLIS MÉDICALE CIE INC | |
37 | 00685447001072 | EWK35-250-12-6A-30-05 | PowerWire RF GuideWire; RFP-100A Connector Cable | PowerWire Radiofrequency GuideWire Kit | BAYLIS MÉDICALE CIE INC | |
38 | 00685447001065 | EWK35-250-12-6A-40-12 | PowerWire RF GuideWire; RFP-100A Connector Cable | PowerWire Radiofrequency GuideWire Kit | BAYLIS MÉDICALE CIE INC | |
39 | 00685447001058 | EWK35-250-12-6S | PowerWire RF GuideWire; RFP-100A Connector Cable | PowerWire Radiofrequency GuideWire Kit | BAYLIS MÉDICALE CIE INC | |
40 | 00685447001041 | EWK35-250-10-6S | PowerWire RF GuideWire; RFP-100A Connector Cable | PowerWire Radiofrequency GuideWire Kit | BAYLIS MÉDICALE CIE INC | |
41 | 00685447001034 | EWK35-250-08-6S | PowerWire RF GuideWire; RFP-100A Connector Cable | PowerWire Radiofrequency GuideWire Kit | BAYLIS MÉDICALE CIE INC | |
42 | 20705032067574 | OTB59120A | OTB59120A | OUTBACK Elite 120cm Re-Entry | OUTBACK | CORDIS CORPORATION |
43 | 20705032067567 | OTB59080A | OTB59080A | OUTBACK Elite 80cm Re-Entry | OUTBACK | CORDIS CORPORATION |
44 | 20705032067536 | MGC39140X | MGC39140X | Support Catheter | ELITECROSS Support Catheter | CORDIS CORPORATION |
45 | 20705032067512 | MGC39140A | MGC39140A | Support Catheter | ELITECROSS Support Catheter | CORDIS CORPORATION |
46 | 20705032067505 | MGC39090X | MGC39090X | Support Catheter | ELITECROSS Support Catheter | CORDIS CORPORATION |
47 | 20705032067482 | MGC39090A | MGC39090A | Support Catheter | ELITECROSS Support Catheter | CORDIS CORPORATION |
48 | 20705032035016 | OTB42120 | OTB42120 | OUTBACK LTD 120cm Re-Entry | OUTBACK | CORDIS CORPORATION |
49 | 17540265105022 | 900-0001291 | The SoundBite® Curving Tool 14 is used by the Physician to curve the tip of the The SoundBite® Curving Tool 14 is used by the Physician to curve the tip of the active wire if desired. Its use is explained in the IFU. | SoundBite® Curving Tool 14 | SOUNDBITE MEDICAL SOLUTIONS INC | |
50 | 17540265103028 | 9AB-C001091 | The SoundBite® Console generates controlled high-amplitude short-duration mechan The SoundBite® Console generates controlled high-amplitude short-duration mechanical pulses (i.e., shock waves) which are transmitted to a connected SoundBite® Active Wire 14P and cause the distal tip of the active wire to move back and forth (axially), acting like a micro-jackhammer. After the passage of each pulse, the tip goes back to its original position. | SoundBite® Console | SOUNDBITE MEDICAL SOLUTIONS INC |