| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 04953170382710 | KD-V451M | KNS | Unit, electrosurgical, endoscopic (with or without accessories) | 2 | Single Use 3-Lumen Needle Knife V | ||
| 2 | 04953170323584 | OTV-S7H-1D-L08E | GCJ | Laparoscope, general & plastic surgery | 2 | CAMERA HEAD | ||
| 3 | 04953170310508 | OLYMPUS CYF-VHA | NWB | Endoscope, accessories, narrow band spectrum | 2 | CYSTO-NEPHRO VIDEOSCOPE | ||
| 4 | 04953170257124 | H-V100 | H-V100 V-HOLDER | FFR | DEVICE, LOCKING, FOR INTESTINAL CLAMP | 1 | ET Control Device V | |
| 5 | 04953170214332 | MAJ-1478 | NEZ | SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE | 2 | CAPSULE ACTIVATOR | ||
| 6 | 04953170208546 | KD-610L | KNS | Unit, electrosurgical, endoscopic (with or without accessories) | 2 | Single Use Electrosurgical Knife | ||
| 7 | 04953170160028 | MAJ-1222 | MAJ-1222 PROTECTION TUBE FOR LTF-160 | FDT | duodenoscope and accessories, flexible/rigid | 2 | PROTECTION TUBE | |
| 8 | 04953170154683 | PR-326Q | ODD | Endoscopic retrograde cholangiopancreatography (ERCP) cannula | 2 | CANNULA | ||
| 9 | 04953170050992 | OLYMPUS ENF-T3 | EOB | NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID) | 2 | RHINO-LARYNGOFIBERSCOPE | ||
| 10 | 04953170435874 | FG-804L | EOB,EOQ | Nasopharyngoscope (flexible or rigid),Bronchoscope (flexible or rigid) | 2 | Single Use Grasping Forceps | ||
| 11 | 04953170435867 | FG-226C | EOQ | Bronchoscope (flexible or rigid) | 2 | Single Use Grasping Forceps | ||
| 12 | 04953170435850 | FG-220P | EOQ,EOB | Bronchoscope (flexible or rigid),Nasopharyngoscope (flexible or rigid) | 2 | Single Use Grasping Forceps | ||
| 13 | 04953170435843 | FG-214P | EOQ,EOB | Bronchoscope (flexible or rigid),Nasopharyngoscope (flexible or rigid) | 2 | Single Use Grasping Forceps | ||
| 14 | 04953170435836 | FG-232L | EOQ | Bronchoscope (flexible or rigid) | 2 | Single Use Grasping Forceps | ||
| 15 | 04953170420313 | OEP-6 | COLOR VIDEO PRINTER OEP-5 | KQM | CAMERA, SURGICAL AND ACCESSORIES | 1 | COLOR VIDEO PRINTER | |
| 16 | 04953170418723 | OEV321UH | GCJ | Laparoscope, General & Plastic Surgery | 2 | 4K UHD LCD MONITOR | ||
| 17 | 04953170418013 | OLYMPUS EU-ME2 | N4506290 | ITX,IYN,IYO,ODG | Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Doppler, Ultrasonic,S Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Doppler, Ultrasonic,System, Imaging, Pulsed Echo, Ultrasonic,Endoscopic Ultrasound System, Gastroenterology-Urology | 2 | EVIS EUS ENDOSCOPIC ULTRASOUND CENTER | |
| 18 | 04953170418006 | OLYMPUS EU-ME2 PREMIER PLUS | N4506090 | IYO,ODG,IYN,ITX | System, Imaging, Pulsed Echo, Ultrasonic,Endoscopic Ultrasound System, Gastroent System, Imaging, Pulsed Echo, Ultrasonic,Endoscopic Ultrasound System, Gastroenterology-Urology,System, Imaging, Pulsed Doppler, Ultrasonic,Transducer, Ultrasonic, Diagnostic | 2 | EVIS EUS ENDOSCOPIC ULTRASOUND CENTER | |
| 19 | 04953170415142 | HX-610-135S | PKL | Hemostatic metal clip for the GI tract | Short Clip | |||
| 20 | 04953170415135 | HX-610-090S | PKL | Hemostatic metal clip for the GI tract | Short Clip | |||
| 21 | 04953170414978 | NM-221C-0427 | FBK | endoscopic injection needle, gastroenterology-urology | 2 | Single Use Injector NM-221C-0427 | ||
| 22 | 04953170412059 | FG-253SX | PTS | Endoscopic grasping/cutting instrument, non-powered, exempt | 2 | Single Use Grasping Forceps FG-253SX | ||
| 23 | 04953170411564 | OLYMPUS HYF TYPE V | VISERA HYSTEROVIDEOSCOPE | HIH | HYSTEROSCOPE (AND ACCESSORIES) | 2 | VISERA HYSTEROVIDEOSCOPE | |
| 24 | 04953170406461 | MAJ-2370 | ODA,GCJ | endoscopic central control unit,Laparoscope, general & plastic surgery | 2 | UCES-4 Upgrade Pack 2 | ||
| 25 | 04953170403392 | OLYMPUS URF-V3R | NWB,FGB,FBN | Endoscope, accessories, narrow band spectrum,Ureteroscope and accessories, flexi Endoscope, accessories, narrow band spectrum,Ureteroscope and accessories, flexible/rigid,Choledochoscope and accessories, flexible/rigid | 2 | URETERO-RENO VIDEOSCOPE | ||
| 26 | 04953170403385 | OLYMPUS URF-V3 | NWB,FBN,FGB | Endoscope, accessories, narrow band spectrum,Choledochoscope and accessories, fl Endoscope, accessories, narrow band spectrum,Choledochoscope and accessories, flexible/rigid,Ureteroscope and accessories, flexible/rigid | 2 | URETERO-RENO VIDEOSCOPE | ||
| 27 | 04953170169892 | OTV-SI | FET | Endoscopic video imaging system/component, gastroenterology-urology | 2 | VIDEO SYSTEM | ||
| 28 | 04953170395321 | FG-V451P | LQR,OCZ | DISLODGER, STONE, BILIARY,Endoscopic grasping/cutting instrument, non-powered | 2 | Single Use Retrieval Nitinol Basket V | ||
| 29 | 04953170391903 | MAJ-2251 | UNIVERSAL INTERFACE | GCJ,ODA | Laparoscope, general & plastic surgery,endoscopic central control unit | 2 | UNIVERSAL INTERFACE | |
| 30 | 04953170391842 | MAJ-2249 | INTERFACE FOR ESU (VIO SERIES) | GCJ,ODA | Laparoscope, general & plastic surgery,endoscopic central control unit | 2 | INTERFACE FOR ESU (VIO SERIES) | |
| 31 | 04953170388323 | NA-U401SX-4022 | FCG | Biopsy needle | 2 | Single Use Aspiration Needle NA-U401SX | ||
| 32 | 04953170388286 | NA-U401SX-4022 | FCG | Biopsy needle | 2 | Single Use Aspiration Needle NA-U401SX | ||
| 33 | 04953170388248 | NA-U401SX-4021 | FCG | Biopsy needle | 2 | Single Use Aspiration Needle NA-U401SX | ||
| 34 | 04953170386817 | USG-400 | KNS,LFL | Unit, electrosurgical, endoscopic (with or without accessories),Instrument, ultr Unit, electrosurgical, endoscopic (with or without accessories),Instrument, ultrasonic surgical | 2 | Ultrasonic Generator | ||
| 35 | 04953170367311 | TJF-Q180V | NWB,FDT | Endoscope, accessories, narrow band spectrum,duodenoscope and accessories, flexible/rigid | 2 | EVIS EXERA II DUODENOVIDEOSCOPE | ||
| 36 | 04953170366901 | OLYMPUS LC-S190-10-30 | GCJ | Laparoscope, general & plastic surgery | 2 | ENDOEYE RIGID LENS CLEANING SHEATH FOR 10MM 30DEGREES | ||
| 37 | 04953170356360 | OLYMPUS BF TYPE UC180F | BF-UC180F ULTRASOUND BRONCHOSCOPE | PSV,IYN,ITX | Ultrasound bronchoscope,System, imaging, pulsed doppler, ultrasonic,Transducer, Ultrasound bronchoscope,System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic | 2 | EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE | |
| 38 | 04953170356353 | OLYMPUS BF TYPE UC180F | IYN,ITX,PSV | System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,U System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic,Ultrasound bronchoscope | 2 | EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE | ||
| 39 | 04953170356056 | MD-743 | FDS,ITX | Gastroscope and accessories, flexible/rigid,Transducer, ultrasonic, diagnostic | 2 | Air/Water Channel Cleaning Adapter | ||
| 40 | 04953170356018 | MAJ-679 | "MAJ-679 EU-M30S footswitch" | ODG | Endoscopic ultrasound system, gastroenterology-urology | 2 | Foot switch | |
| 41 | 04953170355950 | MD-631 | "Y1064SP XENON LAMP W/ LIFE METER MD-631." | FET | Endoscopic video imaging system/component, gastroenterology-urology | 2 | Xenon Lamp | |
| 42 | 04953170355875 | MAJ-1040 | ODG | Endoscopic ultrasound system, gastroenterology-urology | 2 | FOOT SWITCH CABLE | ||
| 43 | 04953170355660 | MAJ-1597 | PSV,IYN,ITX | Ultrasound bronchoscope,System, imaging, pulsed doppler, ultrasonic,Transducer, Ultrasound bronchoscope,System, imaging, pulsed doppler, ultrasonic,Transducer, ultrasonic, diagnostic | 2 | Ultrasonic cable | ||
| 44 | 04953170355608 | OLYMPUS BF TYPE UC180F | PSV,ITX,IYN | Ultrasound bronchoscope,Transducer, ultrasonic, diagnostic,System, imaging, puls Ultrasound bronchoscope,Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic | 2 | EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE | ||
| 45 | 04953170355592 | OLYMPUS BF TYPE UC180F | ITX,IYN,PSV | Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,U Transducer, ultrasonic, diagnostic,System, imaging, pulsed doppler, ultrasonic,Ultrasound bronchoscope | 2 | EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE | ||
| 46 | 04953170353239 | OLYMPUS LC-S190-10-F | GCJ | Laparoscope, general & plastic surgery | ENDOEYE FLEX LENS CLEANING SHEATH FOR 10MM | |||
| 47 | 04953170353192 | OLYMPUS LC-S190-10-F | GCJ | Laparoscope, General & Plastic Surgery | ENDOEYE FLEX LENS CLEANING SHEATH FOR 10MM | |||
| 48 | 04953170351792 | MAJ-2052 | PCV | Endoscopic leak tester | 2 | ALT-PRO INTERFACE CABLE | ||
| 49 | 04953170350597 | MAJ-2081 | HET,GCJ | LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES),Laparoscope, general & plastic surgery | 2 | Sealing cap for MAJ-2079 | ||
| 50 | 04953170343612 | OLYMPUS URF-V2R | "URF-V2R SLIM FLEX VID URETERO SCOPE, REV" | FGB,NWB | Ureteroscope and accessories, flexible/rigid,Endoscope, accessories, narrow band spectrum | 2 | URETERO-RENO VIDEOSCOPE |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00724995184124 | 00711893 | 00711893 | The Oracle EUS latex balloon is intended to be used in endoscopic procedures tha The Oracle EUS latex balloon is intended to be used in endoscopic procedures that utilize a balloon in conjunction with an echoendoscope in the Upper and lower gastrointestinal tract. | Oracle | US ENDOSCOPY |
| 2 | 00724995184117 | 00711892 | 00711892 | The Oracle EUS latex balloon-Olympus radial is used with Olympus radial endoscop The Oracle EUS latex balloon-Olympus radial is used with Olympus radial endoscopes endoscopic procedures that utilize a balloon in conjunction with an echoendoscope in the Upper and lower gastrointestinal tract. | Oracle | US ENDOSCOPY |
| 3 | 00724995184100 | 00711891 | 00711891 | The Oracle EUS Balloon is intended to be used in endoscopic procedures that util The Oracle EUS Balloon is intended to be used in endoscopic procedures that utilize a balloon in conjunction with an echoendoscope in the upper and lower gastrointestinal tract. | Oracle | US ENDOSCOPY |
| 4 | 00724995180539 | 00711780 | 00711780 | The single use BioGuard air/water valve is used to control the air/water functio The single use BioGuard air/water valve is used to control the air/water function of an endoscope during GI endoscopic procedures. The single use BioGuard suction valve is used to control the suction function of an endoscope during GI endoscopic procedures. | BioGuard | US ENDOSCOPY |
| 5 | 00677964094699 | 100313 | Defendo Single Use Valve Kit | MEDIVATORS INC. | ||
| 6 | 00677964094682 | 100312 | Defendo Single Use Valve Kit | MEDIVATORS INC. | ||
| 7 | 00677964092992 | 100322 | DEFENDO SINGLE USE VALVE KIT | MEDIVATORS INC. | ||
| 8 | 00677964090912 | 100311 | Defendo Single Use Valve Kit | MEDIVATORS INC. | ||
| 9 | 00677964067174 | 100320 | 100320 | DEFENDO Disposable Suction and Biopsy Valve Kit | DEFENDO Disposable Suction and Biopsy Valve Kit | MEDIVATORS INC. |
| 10 | 00677964065064 | 100319 | 100319 | DEFENDO Disposable Biopsy Valve | DEFENDO Disposable Biopsy Valve | MEDIVATORS INC. |
| 11 | 00677964060274 | 100306 | DEFENDO Air/Water and Suction Valves | MEDIVATORS INC. | ||
| 12 | 00677964060250 | 100305 | DEFENDO Air/Water/Suction and Biopsy Valve | MEDIVATORS INC. | ||
| 13 | 00677964055935 | 100317 | DEFENDO Air/Water and Suction Valves | MEDIVATORS INC. | ||
| 14 | 00677964055928 | 100316 | DEFENDO Air/Water/Suction and Biopsy Valve | MEDIVATORS INC. | ||
| 15 | 00677964055911 | 100315 | DEFENDO Valve and Connector Kit | MEDIVATORS INC. | ||
| 16 | 00677964052453 | 100310 | DEFENDO Valve and Connector Kit | MEDIVATORS INC. | ||
| 17 | CS5008 | CS-500T | CS-500T | Video Colonoscope | Endoch | ENDOCH INC |
| 18 | CS50078 | CS-500L/T | CS-500L/T | Video Colonoscope | Endoch | ENDOCH INC |
| 19 | CS5007 | CS-500L | CS-500L | Video Colonoscope | Endoch | ENDOCH INC |
| 20 | CS5000 | CS-500 | CS-500 | Video Colonoscope | Endoch | ENDOCH INC |
| 21 | CS4308 | CS-430T | CS-430T | Video Colonoscope | Endoch | ENDOCH INC |
| 22 | CS43078 | CS-430L/T | CS-430L/T | Video Colonoscope | Endoch | ENDOCH INC |
| 23 | CS4307 | CS-430L | CS-430L | Video Colonoscope | Endoch | ENDOCH INC |
| 24 | CS4300 | CS-430 | CS-430 | Video Colonoscope | Endoch | ENDOCH INC |
| 25 | CS3308 | CS-330T | CS-330T | Video Colonoscope | Endoch | ENDOCH INC |
| 26 | CS33078 | CS-330L/T | CS-330L/T | Video Colonoscope | Endoch | ENDOCH INC |
| 27 | CS3307 | CS-330L | CS-330L | Video Colonoscope | Endoch | ENDOCH INC |
| 28 | CS33068 | CS-330S/T | CS-330S/T | Video Colonoscope | Endoch | ENDOCH INC |
| 29 | CS3306 | CS-330S | CS-330S | Video Colonoscope | Endoch | ENDOCH INC |
| 30 | CS3300 | CS-330 | CS-330 | Video Colonoscope | Endoch | ENDOCH INC |
| 31 | 08714729339434 | M00558500 | Esophageal/Colonic Wireguided Balloon Dilatation Catheter | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | |
| 32 | 08714729339427 | M00558490 | Esophageal/Pyloric/Colonic Wireguided Balloon Dilatation Catheter | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | |
| 33 | 08714729339410 | M00558480 | Esophageal/Pyloric/Colonic Wireguided Balloon Dilatation Catheter | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | |
| 34 | 08714729339403 | M00558470 | Esophageal/Pyloric/Colonic Wireguided Balloon Dilatation Catheter | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | |
| 35 | 08714729339397 | M00558460 | Esophageal/Pyloric/Colonic Wireguided Balloon Dilatation Catheter | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | |
| 36 | 08714729339380 | M00558450 | Esophageal/Pyloric/Colonic Wireguided Balloon Dilatation Catheter | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | |
| 37 | 08714729339373 | M00558440 | Esophageal Wireguided Balloon Dilatation Catheter | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | |
| 38 | 08714729339366 | M00558430 | Esophageal/Pyloric Wireguided Balloon Dilatation Catheter | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | |
| 39 | 08714729339359 | M00558420 | Esophageal/Pyloric Wireguided Balloon Dilatation Catheter | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | |
| 40 | 08714729339342 | M00558410 | Esophageal/Pyloric Wireguided Balloon Dilatation Catheter | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | |
| 41 | 08714729339335 | M00558400 | Esophageal/Pyloric Wireguided Balloon Dilatation Catheter | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | |
| 42 | 08714729339328 | M00558390 | Esophageal/Pyloric Wireguided Balloon Dilatation Catheter | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | |
| 43 | 07290018671504 | SPARKC | 40-016 | The G-EYE® System comprises the G-EYE® Colonoscope and the NaviAid™ SPARKC (also The G-EYE® System comprises the G-EYE® Colonoscope and the NaviAid™ SPARKC (also "SPARKC") air control system which controls inflation and deflation of the G-EYE® balloon. The G-EYE® balloon is inflated using ambient air and controlled by the SPARKC via a foot pedal or a remote panel. | NaviAid™ SPARKC | SMART MEDICAL SYSTEMS LTD |
| 44 | 07290018671153 | G-EYE38-i10L | 40-538 | The G-EYE® colonoscope is intended to be used with a compatible video processor The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source),documentation equipment, monitor, endotherapy device such as a biopsy forceps, and other ancillary equipment forendoscopy and endoscopic surgery within the lower gastrointestinal tract including the anus, rectum, sigmoid colon,colon and ileocecal valve. It incorporates a balloon at the distal end of the colonoscope to maintain central positioningwithin the lumen and help control the endoscope’s view field and/or endoscope positioning. | G-EYE Colonoscope | SMART MEDICAL SYSTEMS LTD |
| 45 | 07290018671146 | G-EYE3890LZi | 40-538 | The G-EYE® colonoscope is intended to be used with a compatible video processor The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source),documentation equipment, monitor, endotherapy device such as a biopsy forceps, and other ancillary equipment forendoscopy and endoscopic surgery within the lower gastrointestinal tract including the anus, rectum, sigmoid colon,colon and ileocecal valve. It incorporates a balloon at the distal end of the colonoscope to maintain central positioningwithin the lumen and help control the endoscope’s view field and/or endoscope positioning. | G-EYE Colonoscope | SMART MEDICAL SYSTEMS LTD |
| 46 | 07290018671139 | G-EYE3890Li | 40-538 | The G-EYE® colonoscope is intended to be used with a compatible video processor The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source),documentation equipment, monitor, endotherapy device such as a biopsy forceps, and other ancillary equipment forendoscopy and endoscopic surgery within the lower gastrointestinal tract including the anus, rectum, sigmoid colon,colon and ileocecal valve. It incorporates a balloon at the distal end of the colonoscope to maintain central positioningwithin the lumen and help control the endoscope’s view field and/or endoscope positioning. | G-EYE Colonoscope | SMART MEDICAL SYSTEMS LTD |
| 47 | 07290018671122 | G-EYEH180I | 40-550 | The G-EYE® colonoscope is intended to be used with a compatible video processor The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source),documentation equipment, monitor, endotherapy device such as a biopsy forceps, and other ancillary equipment forendoscopy and endoscopic surgery within the lower gastrointestinal tract including the anus, rectum, sigmoid colon,colon and ileocecal valve. It incorporates a balloon at the distal end of the colonoscope to maintain central positioningwithin the lumen and help control the endoscope’s view field and/or endoscope positioning. | G-EYE Colonoscope | SMART MEDICAL SYSTEMS LTD |
| 48 | 07290018671115 | G-EYEH180AL | 40-550 | The G-EYE® colonoscope is intended to be used with a compatible video processor The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source),documentation equipment, monitor, endotherapy device such as a biopsy forceps, and other ancillary equipment forendoscopy and endoscopic surgery within the lower gastrointestinal tract including the anus, rectum, sigmoid colon,colon and ileocecal valve. It incorporates a balloon at the distal end of the colonoscope to maintain central positioningwithin the lumen and help control the endoscope’s view field and/or endoscope positioning. | G-EYE Colonoscope | SMART MEDICAL SYSTEMS LTD |
| 49 | 07290018671108 | G-EYEQ180I | 40-550 | The G-EYE® colonoscope is intended to be used with a compatible video processor The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source),documentation equipment, monitor, endotherapy device such as a biopsy forceps, and other ancillary equipment forendoscopy and endoscopic surgery within the lower gastrointestinal tract including the anus, rectum, sigmoid colon,colon and ileocecal valve. It incorporates a balloon at the distal end of the colonoscope to maintain central positioningwithin the lumen and help control the endoscope’s view field and/or endoscope positioning. | G-EYE Colonoscope | SMART MEDICAL SYSTEMS LTD |
| 50 | 07290018671092 | G-EYEQ180AL | 40-550 | The G-EYE® colonoscope is intended to be used with a compatible video processor The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source),documentation equipment, monitor, endotherapy device such as a biopsy forceps, and other ancillary equipment forendoscopy and endoscopic surgery within the lower gastrointestinal tract including the anus, rectum, sigmoid colon,colon and ileocecal valve. It incorporates a balloon at the distal end of the colonoscope to maintain central positioningwithin the lumen and help control the endoscope’s view field and/or endoscope positioning. | G-EYE Colonoscope | SMART MEDICAL SYSTEMS LTD |