| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 04961333224685 | KW3115S | FDS | Gastroscope and accessories, flexible/rigid | PENTAX | |||
| 2 | 04961333224562 | KW2411S | EOQ | BRONCHOSCOPE (FLEXIBLE OR RIGID) | PENTAX | |||
| 3 | 14961333221650 | CS-C11A | PROfILE Single Use Endoscope Cleaning Brush Kits | EOB | Nasopharyngoscope (Flexible Or Rigid) | N/A | ||
| 4 | 04961333225569 | EB19-J10U | EOQ | BRONCHOSCOPE (FLEXIBLE OR RIGID) | 2 | N/A | ||
| 5 | 04961333224449 | KW1815S | FDS | Gastroscope and accessories, flexible/rigid | PENTAX | |||
| 6 | 14961333221612 | CS4010A | PROfILE Single Use Endoscope Cleaning Brush Kits | EOB | Nasopharyngoscope (Flexible Or Rigid) | N/A | ||
| 7 | 14961333221438 | OF-B205 | PENTAX Medical single use suction control valve | EOB | Nasopharyngoscope (Flexible Or Rigid) | N/A | ||
| 8 | 04961333251773 | EG17-J10 | PENTAX Medical Video Upper GI Scope EG17-J10 | FDS | Gastroscope and accessories, flexible/rigid | 2 | N/A | |
| 9 | 04961333251506 | EB19-J10 | PENTAX Medical Video Bronchoscope EB19-J10 (Made in Malaysia) | EOQ | BRONCHOSCOPE (FLEXIBLE OR RIGID) | 2 | N/A | |
| 10 | 04961333251810 | EB11-J10 | PENTAX Medical Video Bronchoscope EB11-J10 (Made in Malaysia) | EOQ | BRONCHOSCOPE (FLEXIBLE OR RIGID) | 2 | N/A | |
| 11 | 04961333251803 | EB11-J10 | PENTAX Medical Video Bronchoscope EB11-J10 | EOQ | BRONCHOSCOPE (FLEXIBLE OR RIGID) | 2 | N/A | |
| 12 | 04961333251346 | VNL15-J10 | PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL15-J10 (Made in Malaysia, Ele PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL15-J10 (Made in Malaysia, Electronic IFU) | EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | N/A | |
| 13 | 04961333251322 | VNL15-J10 | PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL15-J10 (Made in Malaysia) | EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | N/A | |
| 14 | 04961333251254 | VNL8-J10 | "PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL8-J10 (Made in Malaysia, Ele "PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL8-J10 (Made in Malaysia, Electronic IFU) | EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | N/A | |
| 15 | 04961333251230 | VNL8-J10 | PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL8-J10 (Made in Malaysia) | EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | N/A | |
| 16 | 04961333251179 | VNL11-J10 | PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL11-J10 (Made in Malaysia, Ele PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL11-J10 (Made in Malaysia, Electronic IFU) | EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | N/A | |
| 17 | 04961333251155 | VNL11-J10 | PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL11-J10 (Made in Malaysia) | EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | N/A | |
| 18 | 04961333249015 | EG38-J10UT | PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT (Made in Malaysia) | ODG,ITX | Endoscopic Ultrasound System, Gastroenterology-Urology,Transducer, Ultrasonic, Diagnostic | 2 | N/A | |
| 19 | 04961333248933 | EG36-J10UR | PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR (Made in Malaysia) | ODG,ITX | Endoscopic Ultrasound System, Gastroenterology-Urology,Transducer, Ultrasonic, Diagnostic | 2 | N/A | |
| 20 | 04961333248858 | EG34-J10U | PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U (Made in Malaysia) | ODG,ITX | Endoscopic Ultrasound System, Gastroenterology-Urology,Transducer, Ultrasonic, Diagnostic | 2 | N/A | |
| 21 | 04961333248315 | EG29-i10 | Made in Malaysia | FDS | Gastroscope and accessories, flexible/rigid | 2 | N/A | |
| 22 | 04961333248209 | EC38-i10L | Made in Malaysia | FDF | Colonoscope and accessories, flexible/rigid | 2 | N/A | |
| 23 | 04961333248179 | EG-2990i | Made in Malaysia | FDS | Gastroscope and accessories, flexible/rigid | 2 | N/A | |
| 24 | 04961333248148 | EC-3890Li | Made in Malaysia | FDF | Colonoscope and accessories, flexible/rigid | 2 | N/A | |
| 25 | 04961333248070 | VNL15-J10 | PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL15-J10 (Electronic IFU) | EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | N/A | |
| 26 | 04961333248063 | VNL8-J10 | PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL8-J10 (Electronic IFU) | EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | N/A | |
| 27 | 04961333248056 | VNL11-J10 | PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL11-J10 (Electronic IFU) | EOB | Nasopharyngoscope (Flexible Or Rigid) | 2 | N/A | |
| 28 | 04961333247455 | ED34-i10T2 | FDT | duodenoscope and accessories, flexible/rigid | 2 | N/A | ||
| 29 | 04961333246632 | ED32-i10 | PENTAX Medical Video Duodenoscope ED32-i10 | FDT | duodenoscope and accessories, flexible/rigid | 2 | N/A | |
| 30 | 04961333245888 | EG34-i10 | FDS | Gastroscope And Accessories, Flexible/Rigid | 2 | N/A | ||
| 31 | 04961333244744 | EPK-3000 | Made in Thailand | PEA | Endoscope, accessories, image post-processing for color enhancement | 2 | DEFINA | |
| 32 | 04961333239696 | EG34-J10U | PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U | ODG,ITX | Endoscopic Ultrasound System, Gastroenterology-Urology,Transducer, Ultrasonic, Diagnostic | 2 | N/A | |
| 33 | 04961333239597 | EG36-J10UR | PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR | ODG,ITX | Endoscopic Ultrasound System, Gastroenterology-Urology,Transducer, Ultrasonic, Diagnostic | 2 | N/A | |
| 34 | 04961333239498 | EG38-J10UT | PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT | ODG,ITX | Endoscopic Ultrasound System, Gastroenterology-Urology,Transducer, Ultrasonic, Diagnostic | 2 | N/A | |
| 35 | 04961333225507 | EB19-J10 | PENTAX Medical Video Bronchoscope EB19-J10 | EOQ | BRONCHOSCOPE (FLEXIBLE OR RIGID) | 2 | N/A | |
| 36 | 04961333225453 | EB15-J10 | PENTAX Medical Video Bronchoscope EB15-J10 | EOQ | BRONCHOSCOPE (FLEXIBLE OR RIGID) | 2 | N/A | |
| 37 | 04961333233618 | EPK-i7010 | PEA | Endoscope, accessories, image post-processing for color enhancement | OPTIVISTA | |||
| 38 | 04961333232918 | EPK-i5500c | PEA | Endoscope, accessories, image post-processing for color enhancement | 2 | IMAGINA | ||
| 39 | 04961333248711 | EC34-i10cL | Made in Malaysia | FDF | Colonoscope and accessories, flexible/rigid | 2 | IMAGINA | |
| 40 | 04961333248544 | EC38-i10cL | Made in Malaysia | FDF | Colonoscope and accessories, flexible/rigid | 2 | IMAGINA | |
| 41 | 04961333248483 | EG29-i10c | Made in Malaysia | FDS | Gastroscope And Accessories, Flexible/Rigid | 2 | IMAGINA | |
| 42 | 04961333247400 | EC38-i10cL | FDF | Colonoscope and accessories, flexible/rigid | 2 | IMAGINA | ||
| 43 | 04961333247394 | EC34-i10cL | FDF | Colonoscope and accessories, flexible/rigid | 2 | IMAGINA | ||
| 44 | 04961333247387 | EG29-i10c | FDS | Gastroscope And Accessories, Flexible/Rigid | 2 | IMAGINA | ||
| 45 | 04961333224821 | KA1811S | FBN | Choledochoscope and accessories, flexible/rigid | 2 | PENTAX | ||
| 46 | 04961333224807 | KH2430S | GCL | ESOPHAGOSCOPE, GENERAL & PLASTIC SURGERY | PENTAX | |||
| 47 | 04961333224784 | KH2422S | GCL | ESOPHAGOSCOPE, GENERAL & PLASTIC SURGERY | PENTAX | |||
| 48 | 04961333224746 | KH2415S | GCL | ESOPHAGOSCOPE, GENERAL & PLASTIC SURGERY | PENTAX | |||
| 49 | 04961333224722 | KH2411S | GCL | ESOPHAGOSCOPE, GENERAL & PLASTIC SURGERY | PENTAX | |||
| 50 | 04961333224708 | KW3122S | FDS | Gastroscope and accessories, flexible/rigid | PENTAX |
| 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 |