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 | 04961333247400 | EC38-i10cL | FDF | Colonoscope and accessories, flexible/rigid | 2 | IMAGINA | ||
44 | 04961333247394 | EC34-i10cL | FDF | Colonoscope and accessories, flexible/rigid | 2 | IMAGINA | ||
45 | 04961333247387 | EG29-i10c | FDS | Gastroscope And Accessories, Flexible/Rigid | 2 | IMAGINA | ||
46 | 04961333224821 | KA1811S | FBN | Choledochoscope and accessories, flexible/rigid | 2 | PENTAX | ||
47 | 04961333224807 | KH2430S | GCL | ESOPHAGOSCOPE, GENERAL & PLASTIC SURGERY | PENTAX | |||
48 | 04961333224784 | KH2422S | GCL | ESOPHAGOSCOPE, GENERAL & PLASTIC SURGERY | PENTAX | |||
49 | 04961333224746 | KH2415S | GCL | ESOPHAGOSCOPE, GENERAL & PLASTIC SURGERY | PENTAX | |||
50 | 04961333224722 | KH2411S | GCL | ESOPHAGOSCOPE, GENERAL & PLASTIC SURGERY | PENTAX |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00607915140175 | CFR39 | Trocar | Kii Optical Access System | APPLIED MEDICAL RESOURCES CORPORATION | |
2 | 00607915137229 | C0H12 | Round Dissecting Balloon with 11mm Introducer | Kii Dissecting Balloon | APPLIED MEDICAL RESOURCES CORPORATION | |
3 | 00607915136703 | C0H11 | Oval dissecting balloon with 11mm Introducer | Kii Dissecting Balloon | APPLIED MEDICAL RESOURCES CORPORATION | |
4 | 00607915136659 | CFF75 | Kii Fios First Entry | APPLIED MEDICAL RESOURCES CORPORATION | ||
5 | 00607915134280 | GTB17 | (1) SPECIMEN CONTAINMENT BAG, 17CM DIAMETER, (1) SMALL GUARD, (1) MEDIUM GUARD, (1) SPECIMEN CONTAINMENT BAG, 17CM DIAMETER, (1) SMALL GUARD, (1) MEDIUM GUARD, (1) RETRACTOR | Alexis® Contained Extraction System | APPLIED MEDICAL RESOURCES CORPORATION | |
6 | 00607915134273 | GTB14 | (1) SPECIMEN CONTAINMENT BAG, 14CM DIAMETER, (1) SMALL GUARD, (1) MEDIUM GUARD, (1) SPECIMEN CONTAINMENT BAG, 14CM DIAMETER, (1) SMALL GUARD, (1) MEDIUM GUARD, (1) RETRACTOR | Alexis® Contained Extraction System | APPLIED MEDICAL RESOURCES CORPORATION | |
7 | 00607915131784 | CNGL3 | Access platform for minimally invasive surgery | GelPOINT® Mini Advanced Access Platform | APPLIED MEDICAL RESOURCES CORPORATION | |
8 | 00607915129910 | CTB75 | Trocar | Kii Shielded Bladed Dual Pack | APPLIED MEDICAL RESOURCES CORPORATION | |
9 | 00607915129903 | CTF75 | Laparoscopic Trocar Sleeve/Single Use | Kii® Fios® Dual Pack | APPLIED MEDICAL RESOURCES CORPORATION | |
10 | 00607915129897 | CTB35 | Trocar | Kii Shielded Bladed Dual Pack | APPLIED MEDICAL RESOURCES CORPORATION | |
11 | 00607915129880 | CTF35 | Trocar | Kii Fios Dual Pack | APPLIED MEDICAL RESOURCES CORPORATION | |
12 | 00607915127602 | C0R95 | Trocars | Kii® Blunt Tip Access System | APPLIED MEDICAL RESOURCES CORPORATION | |
13 | 00607915127480 | EJ450109 | Trocar | Aesculap® Non-Bladed Access System | APPLIED MEDICAL RESOURCES CORPORATION | |
14 | 00607915127473 | EJ450108 | Trocar | Aesculap® Non-Bladed Access System | APPLIED MEDICAL RESOURCES CORPORATION | |
15 | 00607915127466 | EJ450107 | Trocar | Aesculap® Non-Bladed Access System | APPLIED MEDICAL RESOURCES CORPORATION | |
16 | 00607915126773 | CD004 | Tissue Retrieval System | Inzii Retrieval System | APPLIED MEDICAL RESOURCES CORPORATION | |
17 | 00607915126599 | CTB24 | Trocar | Kii Shielded Bladed Dual Pack | APPLIED MEDICAL RESOURCES CORPORATION | |
18 | 00607915126582 | CTB23 | Trocar | Kii Low Profile Bladed Dual Pack | APPLIED MEDICAL RESOURCES CORPORATION | |
19 | 00607915126575 | CTB22 | Trocar | Kii Low Profile Bladed Access System | APPLIED MEDICAL RESOURCES CORPORATION | |
20 | 00607915126568 | CTB21 | Trocar | Kii Low Profile Bladed Access System | APPLIED MEDICAL RESOURCES CORPORATION | |
21 | 00607915126520 | CTS29 | Trocar Sleeve | Kii ® Low Profile Sleeve | APPLIED MEDICAL RESOURCES CORPORATION | |
22 | 00607915126513 | CTR24 | Laparoscopic Trocar Sleeve/Single Use | Kii® Low Profile Optical Dual Pack | APPLIED MEDICAL RESOURCES CORPORATION | |
23 | 00607915126506 | CTR22 | Laparoscopic Trocar Sleeve/Single Use | Kii® Low Profile Optical Access System | APPLIED MEDICAL RESOURCES CORPORATION | |
24 | 00607915126490 | CTS28 | Trocar Sleeve | Kii ® Low Profile Sleeve | APPLIED MEDICAL RESOURCES CORPORATION | |
25 | 00607915126483 | CTR23 | Laparoscopic Trocar Sleeve/Single Use | Kii® Low Profile Optical Dual Pack | APPLIED MEDICAL RESOURCES CORPORATION | |
26 | 00607915126476 | CTR21 | Laparoscopic Trocar Sleeve/Single Use | Kii® Low Profile Optical Access System | APPLIED MEDICAL RESOURCES CORPORATION | |
27 | 00607915125899 | CFB37 | Trocar | Kii Bladed Dual Pack | APPLIED MEDICAL RESOURCES CORPORATION | |
28 | 00607915125875 | CTB37 | Trocar | Kii Bladed Dual Pack | APPLIED MEDICAL RESOURCES CORPORATION | |
29 | 00607915125745 | CFR74 | Trocar | Kii Optical Access System | APPLIED MEDICAL RESOURCES CORPORATION | |
30 | 00607915125738 | CFR34 | Trocar | Kii Optical Access System | APPLIED MEDICAL RESOURCES CORPORATION | |
31 | 00607915125721 | C8702 | Laparoscopic Access System | Alexis Laparoscopic System With Kii Fios First Entry | APPLIED MEDICAL RESOURCES CORPORATION | |
32 | 00607915125714 | C8701 | Laparoscopic Access System | Alexis Laparoscopic System With Kii Fios First Entry | APPLIED MEDICAL RESOURCES CORPORATION | |
33 | 00607915125707 | CTF12 | Trocar | Kii Fios Dual Pack | APPLIED MEDICAL RESOURCES CORPORATION | |
34 | 00607915125677 | CFF10 | Trocar | Kii Fios Dual Pack | APPLIED MEDICAL RESOURCES CORPORATION | |
35 | 00607915125325 | CNGL2 | Access platform for minimally invasive surgery | GelPOINT® Advanced Access Platform | APPLIED MEDICAL RESOURCES CORPORATION | |
36 | 00607915125073 | CTS21 | Laparoscopic Trocar Sleeve/Single Use | Kii® Sleeve | APPLIED MEDICAL RESOURCES CORPORATION | |
37 | 00607915125066 | CTB71 | Trocar | Kii Shielded Bladed Access System | APPLIED MEDICAL RESOURCES CORPORATION | |
38 | 00607915125059 | CTR72 | Trocar | Kii® OPTICAL ACCESS SYSTEM | APPLIED MEDICAL RESOURCES CORPORATION | |
39 | 00607915125042 | CTR71 | Trocar | Kii® OPTICAL ACCESS SYSTEM | APPLIED MEDICAL RESOURCES CORPORATION | |
40 | 00607915125035 | CTF71 | Trocar | Kii Fios First Entry | APPLIED MEDICAL RESOURCES CORPORATION | |
41 | 00607915124878 | C0Q20 | Kii® Balloon Blunt Tip System | APPLIED MEDICAL RESOURCES CORPORATION | ||
42 | 00607915124861 | CTS11 | Trocar | Kii® Sleeve | APPLIED MEDICAL RESOURCES CORPORATION | |
43 | 00607915124854 | CTB31 | Trocar | Kii Shielded Bladed Access System | APPLIED MEDICAL RESOURCES CORPORATION | |
44 | 00607915124847 | CTR32 | Laparoscopic Trocar Sleeve/Single Use | Kii® Optical Access system | APPLIED MEDICAL RESOURCES CORPORATION | |
45 | 00607915124830 | CTR31 | Laparoscopic Trocar Sleeve/Single Use | Kii® Optical Access system | APPLIED MEDICAL RESOURCES CORPORATION | |
46 | 00607915124823 | CTF31 | Trocar | Kii Fios First Entry | APPLIED MEDICAL RESOURCES CORPORATION | |
47 | 00607915124625 | CFR10 | Trocar | Kii Optical Dual Pack | APPLIED MEDICAL RESOURCES CORPORATION | |
48 | 00607915124618 | CFF14 | Trocar | Kii Fios Dual Pack | APPLIED MEDICAL RESOURCES CORPORATION | |
49 | 00607915124267 | CTS12 | Trocar | Kii® Sleeve | APPLIED MEDICAL RESOURCES CORPORATION | |
50 | 00607915124250 | CTB33 | Trocar | Kii Shielded Bladed Access System | APPLIED MEDICAL RESOURCES CORPORATION |