| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00850190004513 | 25327 | Flex Case Kit- Option 7 | EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | FLEX | |
| 2 | 00850190004476 | 50419 | MONOPOLAR MARYLAND DISSECTOR | GCJ | Laparoscope, General & Plastic Surgery | 2 | FLEX | |
| 3 | 00850190004469 | 50220PKG | RETRACTOR BODY | KAL | Retractor, Ent | 1 | FLEX | |
| 4 | 00850190004445 | 50225PKG | TONGUE BLADE, TEXTURED, 50-80MM X 38MM WIDE | KAL | Retractor, Ent | 1 | FLEX | |
| 5 | 00850190004117 | 25463 | TA Drive | EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | Flex | |
| 6 | 00850190004070 | 23157 | FLEX STAND | EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | FLEX | |
| 7 | 00850190004810 | 51075 | Flex Monopolar J-Hook | GCJ | Laparoscope, General & Plastic Surgery | 2 | Flex | |
| 8 | 00850190004766 | 25778 | TO-LX Case Kit Option 3 | EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | Flex | |
| 9 | 00850190004759 | 25777 | TO-LX Case Kit Option 2 | EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | Flex | |
| 10 | 00850190004742 | 25776 | TO-LX Case Kit Option 1 | EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | Flex | |
| 11 | 00850190004728 | 50931 | Bipolar Maryland Dissector | GCJ | Laparoscope, General & Plastic Surgery | 2 | Flex | |
| 12 | 00850190004704 | 50710PKG | Hypercurved Laryngeal Blade, 92-125mm x 36mm Wide | KAL | Retractor, Ent | 1 | Flex | |
| 13 | 00850190004698 | 50709PKG | Hypercurved Laryngeal Blade, 120-150mm x 36mm Wide | KAL | Retractor, Ent | 1 | Flex | |
| 14 | 00850190004681 | 50644 | Micro Flex Laser Holder 1100 | GCJ | Laparoscope, General & Plastic Surgery | 2 | Flex | |
| 15 | 00850190004674 | 50474 | Needle Driver | GCJ | Laparoscope, General & Plastic Surgery | 2 | Flex | |
| 16 | 00850190004667 | 50639 | Micro Flex Triangle Forceps | GCJ | Laparoscope, General & Plastic Surgery | 2 | Flex | |
| 17 | 00850190004650 | 50642 | Micro Flex Alligator Grasper | GCJ | Laparoscope, General & Plastic Surgery | 2 | Flex | |
| 18 | 00850190004643 | 50641 | Micro Flex Sickle Knife | GCJ | Laparoscope, General & Plastic Surgery | 2 | Flex | |
| 19 | 00850190004636 | 50640 | Micro Flex Scissors | GCJ | Laparoscope, General & Plastic Surgery | 2 | Flex | |
| 20 | 00850190004100 | 25171 | Flex Rectoscope | FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | Flex | |
| 21 | 00850190004193 | 25386 | 3D Camera | EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | Flex | |
| 22 | 00850190004155 | 24324-L | TO-LX Drive | EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | Flex | |
| 23 | 00850190004124 | 25173 | TA Instrument Support | EOB | Nasopharyngoscope (Flexible Or Rigid) | Flex | ||
| 24 | 00850190004872 | 50951 | Precision Anchor | KAL | Retractor, Ent | 1 | FLEX | |
| 25 | 00850190004865 | 26473 | TA Case Kit 4 | FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | FLEX | |
| 26 | 00850190004858 | 26472 | TA Case Kit 3 | FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | FLEX | |
| 27 | 00850190004841 | 26471 | TA Case Kit 2 | FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | FLEX | |
| 28 | 00850190004834 | 26470 | TA Case Kit 1 | FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | FLEX | |
| 29 | 00850190004827 | 26114 | Obturator, 4.5cm | FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | FLEX | |
| 30 | 00850190004735 | 50937 | Monopolar L-Hook | GCJ | Laparoscope, General & Plastic Surgery | 2 | FLEX | |
| 31 | 00850190004568 | 25332 | Flex Case Kit - Option 12 | EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | FLEX | |
| 32 | 00850190004551 | 25331 | Flex Case Kit - Option 11 | EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | FLEX | |
| 33 | 00850190004544 | 25330 | Flex Case Kit- Option 10 | EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | FLEX | |
| 34 | 00850190004537 | 25329 | Flex Case Kit - Option 9 | EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | FLEX | |
| 35 | 00850190004520 | 25328 | Flex Case Kit- Option 8 | EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | FLEX | |
| 36 | 00850190004506 | 50421 | MONOPOLAR SPATULA | GCJ | Laparoscope, General & Plastic Surgery | 2 | FLEX | |
| 37 | 00850190004490 | 50420 | MONOPOLAR NEEDLE KNIFE | GCJ | Laparoscope, General & Plastic Surgery | 2 | FLEX | |
| 38 | 00850190004483 | 50418 | FENESTRATED GRASPER | GCJ | Laparoscope, General & Plastic Surgery | 2 | FLEX | |
| 39 | 00850190004452 | 50226PKG | TONGUE BLADE, TEXTURED, 80-110MM X 32MM WIDE | KAL | Retractor, Ent | 1 | FLEX | |
| 40 | 00850190004438 | 50224PKG | TONGUE BLADE, TEXTURED, 50-80MM X 32MM WIDE | KAL | Retractor, Ent | 1 | FLEX | |
| 41 | 00850190004421 | 50208PKG | FLEX CURVED LARYNGEAL BLADE, 130-160mm X 36mm Proximal X 16mm Distal | KAL | Retractor, Ent | 1 | FLEX | |
| 42 | 00850190004414 | 50207PKG | CURVED LARYNGEAL BLADE, 85-115mm X 36mm Proximal X 23mm Distal | KAL | Retractor, Ent | 1 | FLEX | |
| 43 | 00850190004407 | 50206PKG | FLEX STRAIGHT LARYNGEAL BLADE, 130-160mm X 36mm Proximal X 16mm Distal | KAL | Retractor, Ent | 1 | FLEX | |
| 44 | 00850190004711 | 25597 | Flex TA Instrument Support & Assembly | EOB | Nasopharyngoscope (Flexible Or Rigid) | FLEX | ||
| 45 | 00850190004889 | 25171 | Rectoscope, Body Long | FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | FLEX | |
| 46 | 00850190004940 | 26570 | Flex Precision Anchor & Assembly | KAL | Retractor, Ent | 1 | FLEX | |
| 47 | 00850190004933 | Instrument Assembly part | Clamp | EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | FLEX | |
| 48 | 00850190004926 | Instrument Assembly part | Support Arm | EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | FLEX | |
| 49 | 00850190004919 | 25171 | Short Obturator Cone | FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | FLEX | |
| 50 | 00850190004902 | 25171 | Long Obturator Cone | FDF | Colonoscope And Accessories, Flexible/Rigid | 2 | FLEX |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00817658020195 | FSA-7501 | FSA-7501 | When added scope stiffness is desired to negotiate a difficult colon, and prior When added scope stiffness is desired to negotiate a difficult colon, and prior to re positioning the patient, simply insert the Colonoscope Stiffening Device into the biopsy port to stiffen the insertion tube and advance to the cecum. The device is then withdrawn and the procedure is completed as usual.These reusable devices are compatible with Pentax ®, Fujinon®, Olympus® and Fuse® non-variable stiffness endoscopes. | Endochoice Drive Wire | ZUTRON MEDICAL, L.L.C. |
| 2 | 00817658020188 | ZUTR162000 | ZUTR162000 | The patented Endoscope Stiffening System (ESS) consists of the Colonoscope Stiff The patented Endoscope Stiffening System (ESS) consists of the Colonoscope Stiffening Device and Enteroscope StiffeningDevice.These are reusable devices that provide a simple way to temporarily stiffen the insertion tube of an endoscope during a procedure when difficult anatomy presents itself. They are compatible with Pentax ®, Fujinon®, and Olympus® non-variable stiffness endoscopes. | Zutron Medical | ZUTRON MEDICAL, L.L.C. |
| 3 | 00817658020164 | ZUTR161700 | ZUTR161700 | When added scope siffness is desired to negotiate a difficult colon, and prior t When added scope siffness is desired to negotiate a difficult colon, and prior to repositioning the patient, simply insert the Colonoscope Stiffening Device into the biopsy port to stiffen the insertion tube and advance to the cecum. The device is then withdrawn and the procedure is completed as usual.These reusable devices are compatible with Pentax ®, Fujinon®, Olympus® and Fuse® non-variable stiffness endoscopes. | Zutron Medical | ZUTRON MEDICAL, L.L.C. |
| 4 | 00817658020157 | ZUTR141700 | ZUTR141700 | When added scope siffness is desired to negotiate a difficult colon, and prior t When added scope siffness is desired to negotiate a difficult colon, and prior to repositioning the patient, simply insert the Colonoscope Stiffening Device into the biopsy port to stiffen the insertion tube and advance to the cecum. The device is then withdrawn and the procedure is completed as usual.These reusable devices are compatible with Pentax ®, Fujinon®, Olympus® and Fuse® non-variable stiffness endoscopes. | Zutron Medical | ZUTRON MEDICAL, L.L.C. |
| 5 | 00816849019666 | FSC330-F7527 | Colonoscope | Fuse® | ENDOCHOICE, INC. | |
| 6 | 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 |
| 7 | 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 |
| 8 | 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 |
| 9 | 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 |
| 10 | 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 |
| 11 | 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 |
| 12 | 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 |
| 13 | 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 |
| 14 | 00677964094699 | 100313 | Defendo Single Use Valve Kit | MEDIVATORS INC. | ||
| 15 | 00677964094682 | 100312 | Defendo Single Use Valve Kit | MEDIVATORS INC. | ||
| 16 | 00677964092992 | 100322 | DEFENDO SINGLE USE VALVE KIT | MEDIVATORS INC. | ||
| 17 | 00677964090912 | 100311 | Defendo Single Use Valve Kit | MEDIVATORS INC. | ||
| 18 | 00677964067174 | 100320 | 100320 | DEFENDO Disposable Suction and Biopsy Valve Kit | DEFENDO Disposable Suction and Biopsy Valve Kit | MEDIVATORS INC. |
| 19 | 00677964065064 | 100319 | 100319 | DEFENDO Disposable Biopsy Valve | DEFENDO Disposable Biopsy Valve | MEDIVATORS INC. |
| 20 | 00677964060274 | 100306 | DEFENDO Air/Water and Suction Valves | MEDIVATORS INC. | ||
| 21 | 00677964060250 | 100305 | DEFENDO Air/Water/Suction and Biopsy Valve | MEDIVATORS INC. | ||
| 22 | 00677964055935 | 100317 | DEFENDO Air/Water and Suction Valves | MEDIVATORS INC. | ||
| 23 | 00677964055928 | 100316 | DEFENDO Air/Water/Suction and Biopsy Valve | MEDIVATORS INC. | ||
| 24 | 00677964055911 | 100315 | DEFENDO Valve and Connector Kit | MEDIVATORS INC. | ||
| 25 | 00677964052453 | 100310 | DEFENDO Valve and Connector Kit | MEDIVATORS INC. | ||
| 26 | CS5008 | CS-500T | CS-500T | Video Colonoscope | Endoch | ENDOCH INC |
| 27 | CS50078 | CS-500L/T | CS-500L/T | Video Colonoscope | Endoch | ENDOCH INC |
| 28 | CS5007 | CS-500L | CS-500L | Video Colonoscope | Endoch | ENDOCH INC |
| 29 | CS5000 | CS-500 | CS-500 | Video Colonoscope | Endoch | ENDOCH INC |
| 30 | CS4308 | CS-430T | CS-430T | Video Colonoscope | Endoch | ENDOCH INC |
| 31 | CS43078 | CS-430L/T | CS-430L/T | Video Colonoscope | Endoch | ENDOCH INC |
| 32 | CS4307 | CS-430L | CS-430L | Video Colonoscope | Endoch | ENDOCH INC |
| 33 | CS4300 | CS-430 | CS-430 | Video Colonoscope | Endoch | ENDOCH INC |
| 34 | CS3308 | CS-330T | CS-330T | Video Colonoscope | Endoch | ENDOCH INC |
| 35 | CS33078 | CS-330L/T | CS-330L/T | Video Colonoscope | Endoch | ENDOCH INC |
| 36 | CS3307 | CS-330L | CS-330L | Video Colonoscope | Endoch | ENDOCH INC |
| 37 | CS33068 | CS-330S/T | CS-330S/T | Video Colonoscope | Endoch | ENDOCH INC |
| 38 | CS3306 | CS-330S | CS-330S | Video Colonoscope | Endoch | ENDOCH INC |
| 39 | CS3300 | CS-330 | CS-330 | Video Colonoscope | Endoch | ENDOCH INC |
| 40 | 08714729339434 | M00558500 | Esophageal/Colonic Wireguided Balloon Dilatation Catheter | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | |
| 41 | 08714729339427 | M00558490 | Esophageal/Pyloric/Colonic Wireguided Balloon Dilatation Catheter | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | |
| 42 | 08714729339410 | M00558480 | Esophageal/Pyloric/Colonic Wireguided Balloon Dilatation Catheter | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | |
| 43 | 08714729339403 | M00558470 | Esophageal/Pyloric/Colonic Wireguided Balloon Dilatation Catheter | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | |
| 44 | 08714729339397 | M00558460 | Esophageal/Pyloric/Colonic Wireguided Balloon Dilatation Catheter | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | |
| 45 | 08714729339380 | M00558450 | Esophageal/Pyloric/Colonic Wireguided Balloon Dilatation Catheter | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | |
| 46 | 08714729339373 | M00558440 | Esophageal Wireguided Balloon Dilatation Catheter | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | |
| 47 | 08714729339366 | M00558430 | Esophageal/Pyloric Wireguided Balloon Dilatation Catheter | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | |
| 48 | 08714729339359 | M00558420 | Esophageal/Pyloric Wireguided Balloon Dilatation Catheter | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | |
| 49 | 08714729339342 | M00558410 | Esophageal/Pyloric Wireguided Balloon Dilatation Catheter | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION | |
| 50 | 08714729339335 | M00558400 | Esophageal/Pyloric Wireguided Balloon Dilatation Catheter | CRE Wireguided | BOSTON SCIENTIFIC CORPORATION |