| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00816849010038 | DBL-359 | Ligator Assembly & Band Barrel w/7 non-Latex Bands | MND | Ligator, Esophageal | 2 | Auto-Band® | |
| 2 | 00816849010021 | DBL-358 | Ligator Assembly & Band Barrel w/7 Latex Bands | MND | Ligator, Esophageal | 2 | Auto-Band® | |
| 3 | 00816849010014 | DBL-293 | Ligator Assembly & Band Barrel w/7 Latex Bands | MND | Ligator, Esophageal | 2 | Auto-Band® | |
| 4 | 00816849010007 | DBL-330 | Ligator Assembly & Band Barrel w/7 non-Latex Bands | MND | Ligator, Esophageal | 2 | Auto-Band® | |
| 5 | 00840253109606 | FSC330-G7531 | Colonoscope | FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | Fuse® | |
| 6 | 00816849019666 | FSC330-F7527 | Colonoscope | FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | Fuse® | |
| 7 | 00840253114327 | FSP-100-AR-R | FSP-100-AR-R | Endoscopic Video Processor Unit | FDS | Gastroscope And Accessories, Flexible/Rigid | 2 | FuseBox |
| 8 | 00840253114310 | FSP-100-R | FSP-100-R | Endoscopic Processor Unit | FDS | Gastroscope And Accessories, Flexible/Rigid | 2 | FuseBox |
| 9 | 00840253104274 | LS-FSP-100-AR | LS-FSP-100-AR | Endoscopic Video Processor Unit | FDS | Gastroscope And Accessories, Flexible/Rigid | 2 | FuseBox |
| 10 | 00840253104267 | LS-FSP-100 | LS-FSP-100 | Endoscopic Video Processor Unit | FDS | Gastroscope And Accessories, Flexible/Rigid | 2 | FuseBox |
| 11 | 00840253103932 | FSP-100-AR | FSP-100-AR | Endoscopic video image processor | FDS | Gastroscope And Accessories, Flexible/Rigid | 2 | FuseBox |
| 12 | 00840253109590 | FSC330-G7530 | Colonoscope | FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | Fuse® | |
| 13 | 00816849017303 | DGA-274 | Alligator Grasping Forceps | OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | Rescue® | ||
| 14 | 00840253109576 | FSC330-F7528 | FSC330-F7528 | Fuse C38 Colonoscope (150 cm) | FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | Fuse® |
| 15 | 00816849017310 | DGA-275 | Alligator Grasping Forceps , Long | OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | Rescue® | ||
| 16 | 00816849017341 | DGR-277 | Rat tooth Grasping Forceps - Pediatric | OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | Rescue® | ||
| 17 | 00816849017334 | DGR-276 | Rat tooth Grasping Forceps | OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | Rescue® | ||
| 18 | 00816849017327 | DGC-383 | Rat tooth/Alligator Grasping Forceps | OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | Rescue® | ||
| 19 | 00840253109927 | FSC330-G7522 | Colonoscope | FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | Fuse® | |
| 20 | 00840253109910 | FSC330-G7521 | Colonoscope | FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | Fuse® | |
| 21 | 00840253109866 | FSC330-G7520 | Colonoscope | FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | Fuse® | |
| 22 | 00840253109859 | FSC330-F7525 | Colonoscope | FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | Fuse® | |
| 23 | 00840253109842 | FSC330-F7524 | Colonoscope | FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | Fuse® | |
| 24 | 00840253109835 | FSC330-F7523 | Colonoscope | FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | Fuse® | |
| 25 | 00840253109828 | FSG250-H7642 | Gastroscope | FDS | Gastroscope And Accessories, Flexible/Rigid | 2 | Fuse® | |
| 26 | 00840253109811 | FSG250-H7641 | Gastroscope | FDS | Gastroscope And Accessories, Flexible/Rigid | 2 | Fuse® | |
| 27 | 00840253109583 | FSC330-G7529 | Colonoscope | FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | Fuse® | |
| 28 | 00840253111142 | LS-FSG250-H7642 | Gastroscope | FDS | Gastroscope And Accessories, Flexible/Rigid | 2 | Fuse® | |
| 29 | 00840253111135 | LS-FSG250-H7641 | Gastroscope | FDS | Gastroscope And Accessories, Flexible/Rigid | 2 | Fuse® | |
| 30 | 00840253111128 | LS-FSC330-G7529 | Colonoscope | FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | Fuse® | |
| 31 | 00840253111111 | LS-FSC330-G7522 | Colonoscope | FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | Fuse® | |
| 32 | 00840253111104 | LS-FSC330-G7521 | Colonoscope | FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | Fuse® | |
| 33 | 00840253111098 | LS-FSC330-G7520 | Colonoscope | FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | Fuse® | |
| 34 | 00840253111081 | LS-FSC330-F7526 | Colonoscope | FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | Fuse® | |
| 35 | 00840253111074 | LS-FSC330-F7525 | Colonoscope | FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | Fuse® | |
| 36 | 00840253111067 | LS-FSC330-F7524 | Colonoscope | FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | Fuse® | |
| 37 | 00840253111050 | LS-FSC330-F7523 | Colonoscope | FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | Fuse® | |
| 38 | 00840253111043 | FDEMO-H7642 | Gastroscope | FDS | Gastroscope And Accessories, Flexible/Rigid | 2 | Fuse® | |
| 39 | 00840253110848 | FDEMO-H7641 | Gastroscope | FDS | Gastroscope And Accessories, Flexible/Rigid | 2 | Fuse® | |
| 40 | 00840253110831 | FDEMO-G7529 | Colonoscope | FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | Fuse® | |
| 41 | 00840253110824 | FDEMO-G7522 | Colonoscope | FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | Fuse® | |
| 42 | 00840253110817 | FDEMO-G7521 | Colonoscope | FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | Fuse® | |
| 43 | 00840253110800 | FDEMO-G7520 | Colonoscope | FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | Fuse® | |
| 44 | 00840253110794 | FDEMO-F7528 | Colonoscope | FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | Fuse® | |
| 45 | 00840253110046 | FDEMO-F7526 | Colonoscope | FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | Fuse® | |
| 46 | 00840253109552 | FSC330-F7526 | Colonoscope | FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | Fuse® | |
| 47 | 00840253109545 | FDEMO-F7525 | Colonoscope | FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | Fuse® | |
| 48 | 00840253109538 | FDEMO-F7524 | Colonoscope | FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | Fuse® | |
| 49 | 00840253109521 | FDEMO-F7523 | Colonoscope | FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | Fuse® | |
| 50 | 00840253101228 | SCT-469 | Water bottle cap with CO2, Reusable | FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | Fuse® |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00816849019666 | FSC330-F7527 | Colonoscope | Fuse® | ENDOCHOICE, INC. | |
| 2 | 00816765013458 | 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 |
| 3 | 00816765013441 | 00711892 | 00711892 | The Oracle EUS latex balloon- Olympus radial is used with Olympus radial endosco 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 |
| 4 | 00816765012772 | 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 | 00816765011935 | 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 |
| 6 | 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 |
| 7 | 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 |
| 8 | 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 |
| 9 | 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 |
| 10 | 00677964094699 | 100313 | Defendo Single Use Valve Kit | MEDIVATORS INC. | ||
| 11 | 00677964094682 | 100312 | Defendo Single Use Valve Kit | MEDIVATORS INC. | ||
| 12 | 00677964092992 | 100322 | DEFENDO SINGLE USE VALVE KIT | MEDIVATORS INC. | ||
| 13 | 00677964090912 | 100311 | Defendo Single Use Valve Kit | MEDIVATORS INC. | ||
| 14 | 00677964067174 | 100320 | 100320 | DEFENDO Disposable Suction and Biopsy Valve Kit | DEFENDO Disposable Suction and Biopsy Valve Kit | MEDIVATORS INC. |
| 15 | 00677964065064 | 100319 | 100319 | DEFENDO Disposable Biopsy Valve | DEFENDO Disposable Biopsy Valve | MEDIVATORS INC. |
| 16 | 00677964060274 | 100306 | DEFENDO Air/Water and Suction Valves | MEDIVATORS INC. | ||
| 17 | 00677964060250 | 100305 | DEFENDO Air/Water/Suction and Biopsy Valve | MEDIVATORS INC. | ||
| 18 | 00677964055935 | 100317 | DEFENDO Air/Water and Suction Valves | MEDIVATORS INC. | ||
| 19 | 00677964055928 | 100316 | DEFENDO Air/Water/Suction and Biopsy Valve | MEDIVATORS INC. | ||
| 20 | 00677964055911 | 100315 | DEFENDO Valve and Connector Kit | MEDIVATORS INC. | ||
| 21 | 00677964052453 | 100310 | DEFENDO Valve and Connector Kit | MEDIVATORS INC. | ||
| 22 | CS5008 | CS-500T | CS-500T | Video Colonoscope | Endoch | ENDOCH INC |
| 23 | CS50078 | CS-500L/T | CS-500L/T | Video Colonoscope | Endoch | ENDOCH INC |
| 24 | CS5007 | CS-500L | CS-500L | Video Colonoscope | Endoch | ENDOCH INC |
| 25 | CS5000 | CS-500 | CS-500 | Video Colonoscope | Endoch | ENDOCH INC |
| 26 | CS4308 | CS-430T | CS-430T | Video Colonoscope | Endoch | ENDOCH INC |
| 27 | CS43078 | CS-430L/T | CS-430L/T | Video Colonoscope | Endoch | ENDOCH INC |
| 28 | CS4307 | CS-430L | CS-430L | Video Colonoscope | Endoch | ENDOCH INC |
| 29 | CS4300 | CS-430 | CS-430 | Video Colonoscope | Endoch | ENDOCH INC |
| 30 | CS3308 | CS-330T | CS-330T | Video Colonoscope | Endoch | ENDOCH INC |
| 31 | CS33078 | CS-330L/T | CS-330L/T | Video Colonoscope | Endoch | ENDOCH INC |
| 32 | CS3307 | CS-330L | CS-330L | Video Colonoscope | Endoch | ENDOCH INC |
| 33 | CS33068 | CS-330S/T | CS-330S/T | Video Colonoscope | Endoch | ENDOCH INC |
| 34 | CS3306 | CS-330S | CS-330S | Video Colonoscope | Endoch | ENDOCH INC |
| 35 | CS3300 | CS-330 | CS-330 | Video Colonoscope | Endoch | ENDOCH INC |
| 36 | 08714729339434 | M00558500 | Esophageal/Colonic Wireguided Balloon Dilatation Catheter | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | |
| 37 | 08714729339427 | M00558490 | Esophageal/Pyloric/Colonic Wireguided Balloon Dilatation Catheter | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | |
| 38 | 08714729339410 | M00558480 | Esophageal/Pyloric/Colonic Wireguided Balloon Dilatation Catheter | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | |
| 39 | 08714729339403 | M00558470 | Esophageal/Pyloric/Colonic Wireguided Balloon Dilatation Catheter | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | |
| 40 | 08714729339397 | M00558460 | Esophageal/Pyloric/Colonic Wireguided Balloon Dilatation Catheter | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | |
| 41 | 08714729339380 | M00558450 | Esophageal/Pyloric/Colonic Wireguided Balloon Dilatation Catheter | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | |
| 42 | 08714729339373 | M00558440 | Esophageal Wireguided Balloon Dilatation Catheter | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | |
| 43 | 08714729339366 | M00558430 | Esophageal/Pyloric Wireguided Balloon Dilatation Catheter | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | |
| 44 | 08714729339359 | M00558420 | Esophageal/Pyloric Wireguided Balloon Dilatation Catheter | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | |
| 45 | 08714729339342 | M00558410 | Esophageal/Pyloric Wireguided Balloon Dilatation Catheter | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | |
| 46 | 08714729339335 | M00558400 | Esophageal/Pyloric Wireguided Balloon Dilatation Catheter | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | |
| 47 | 08714729339328 | M00558390 | Esophageal/Pyloric Wireguided Balloon Dilatation Catheter | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | |
| 48 | 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 |
| 49 | 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 |
| 50 | 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 |