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 | 04961333245895 | EC34-i10TL | FDF | Colonoscope and accessories, flexible/rigid | 2 | N/A | ||
31 | 04961333245888 | EG34-i10 | FDS | Gastroscope And Accessories, Flexible/Rigid | 2 | N/A | ||
32 | 04961333244744 | EPK-3000 | Made in Thailand | PEA | Endoscope, accessories, image post-processing for color enhancement | 2 | DEFINA | |
33 | 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 | |
34 | 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 | |
35 | 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 | |
36 | 04961333225507 | EB19-J10 | PENTAX Medical Video Bronchoscope EB19-J10 | EOQ | BRONCHOSCOPE (FLEXIBLE OR RIGID) | 2 | N/A | |
37 | 04961333225453 | EB15-J10 | PENTAX Medical Video Bronchoscope EB15-J10 | EOQ | BRONCHOSCOPE (FLEXIBLE OR RIGID) | 2 | N/A | |
38 | 04961333233618 | EPK-i7010 | PEA | Endoscope, accessories, image post-processing for color enhancement | OPTIVISTA | |||
39 | 04961333232918 | EPK-i5500c | PEA | Endoscope, accessories, image post-processing for color enhancement | 2 | IMAGINA | ||
40 | 04961333248711 | EC34-i10cL | Made in Malaysia | FDF | Colonoscope and accessories, flexible/rigid | 2 | IMAGINA | |
41 | 04961333248544 | EC38-i10cL | Made in Malaysia | FDF | Colonoscope and accessories, flexible/rigid | 2 | IMAGINA | |
42 | 04961333248483 | EG29-i10c | Made in Malaysia | FDS | Gastroscope 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 | 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 |