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 | 00865309000249 | DiLumen C2 168 cm | D-2000 | DiLumen C2 consists of a soft flexible sheath that fits over standard endoscopes DiLumen C2 consists of a soft flexible sheath that fits over standard endoscopes. The device employs two balloons, one behind the bending section of the endoscope and the second in front of the tip of the endoscope. When both balloons are deployed, and inflated the area in between is stabilized. This Therapeutic Zone (TZ) facilitates stabilization, insufflation and manipulation of the tissue thus allowing the clinician to effectively treat the target area. The device also has two flexible tool channels attached on the outside of the sleeve at the 3 and 6 o'clock positions. These tool channels accommodate flexible endoscopic instruments used to perform endoscopic interventions. | DiLumen C2 | LUMENDI LLC |
2 | 00865309000232 | DiLumen, 103 cm | D-1002 | DiLumen consists of a soft flexible sheath that fits over standard colonoscopes. DiLumen consists of a soft flexible sheath that fits over standard colonoscopes. The device employs two balloons, one behind the bending section of the colonoscope and the second in front of the tip of the colonoscope. When both balloons are deployed, and inflated the area in between is stabilized. This Therapeutic Zone (TZ) facilitates stabilization, insufflation and manipulation of the tissue thus allowing the clinician to effectively treat the target area. | DiLumen Endolumenal Interventional Platform, 103 cm | LUMENDI LLC |
3 | 00865309000225 | DiLumen, 130 cm | D-1001 | DiLumen consists of a soft flexible sheath that fits over standard colonoscopes. DiLumen consists of a soft flexible sheath that fits over standard colonoscopes. The device employs two balloons, one behind the bending section of the colonoscope and the second in front of the tip of the colonoscope. When both balloons are deployed, and inflated the area in between is stabilized. This Therapeutic Zone (TZ) facilitates stabilization, insufflation and manipulation of the tissue thus allowing the clinician to effectively treat the target area. | DiLumen Endolumenal Interventional Platform, 130 cm | LUMENDI LLC |
4 | 00865309000201 | DiLumen | D-1000 | DiLumen consists of a soft flexible sheath that fits over standard colonoscopes. DiLumen consists of a soft flexible sheath that fits over standard colonoscopes. The device employs two balloons, one behind the bending section of the colonoscope and the second in front of the tip of the colonoscope. When both balloons are deployed, and inflated the area in between is stabilized. This Therapeutic Zone (TZ) facilitates stabilization, insufflation and manipulation of the tissue thus allowing the clinician to effectively treat the target area. | DiLumen Endolumenal Interventional Platform | LUMENDI LLC |
5 | 00858836007089 | DiLumen C2.2 103 cm | D-2005 | DiLumen C2 consists of a soft flexible sheath that fits over standard endoscopes DiLumen C2 consists of a soft flexible sheath that fits over standard endoscopes. The device employs two balloons, one behind the bending section of the endoscope and the second in front of the tip of the endoscope. When both balloons are deployed, and inflated the area in between is stabilized. This Therapeutic Zone (TZ) facilitates stabilization, insufflation and manipulation of the tissue thus allowing the clinician to effectively treat the target area. The device also has two flexible tool channels attached on the outside of the sleeve at the 3 and 6 o'clock positions. These tool channels accommodate flexible endoscopic instruments used to perform endoscopic interventions. This DiLumen C2 version is designed to be used with the DiLumen Elbow Ig grasper. | DiLumen C2 | LUMENDI LLC |
6 | 00858836007065 | DiLumen C2.2 130 cm | D-2004 | DiLumen C2 consists of a soft flexible sheath that fits over standard endoscopes DiLumen C2 consists of a soft flexible sheath that fits over standard endoscopes. The device employs two balloons, one behind the bending section of the endoscope and the second in front of the tip of the endoscope. When both balloons are deployed, and inflated the area in between is stabilized. This Therapeutic Zone (TZ) facilitates stabilization, insufflation and manipulation of the tissue thus allowing the clinician to effectively treat the target area. The device also has two flexible tool channels attached on the outside of the sleeve at the 3 and 6 o'clock positions. These tool channels accommodate flexible endoscopic instruments used to perform endoscopic interventions. This version DiLumen C2 is designed to work with the DiLumen Elbow Ig. | DiLumen C2 | LUMENDI LLC |
7 | 00858836007034 | DiLumen C2 103 cm | D-2002 | DiLumen C2 consists of a soft flexible sheath that fits over standard endoscopes DiLumen C2 consists of a soft flexible sheath that fits over standard endoscopes. The device employs two balloons, one behind the bending section of the endoscope and the second in front of the tip of the endoscope. When both balloons are deployed, and inflated the area in between is stabilized. This Therapeutic Zone (TZ) facilitates stabilization, insufflation and manipulation of the tissue thus allowing the clinician to effectively treat the target area. The device also has two flexible tool channels attached on the outside of the sleeve at the 3 and 6 o'clock positions. These tool channels accommodate flexible endoscopic instruments used to perform endoscopic interventions. | DiLumen C2 | LUMENDI LLC |
8 | 00858836007027 | DiLumen C2 130 cm | D-2001 | DiLumen C2 consists of a soft flexible sheath that fits over standard endoscopes DiLumen C2 consists of a soft flexible sheath that fits over standard endoscopes. The device employs two balloons, one behind the bending section of the endoscope and the second in front of the tip of the endoscope. When both balloons are deployed, and inflated the area in between is stabilized. This Therapeutic Zone (TZ) facilitates stabilization, insufflation and manipulation of the tissue thus allowing the clinician to effectively treat the target area. The device also has two flexible tool channels attached on the outside of the sleeve at the 3 and 6 o'clock positions. These tool channels accommodate flexible endoscopic instruments used to perform endoscopic interventions. | DiLumen C2 | LUMENDI LLC |
9 | 00850190004919 | 25171 | Short Obturator Cone | FLEX | MEDROBOTICS CORPORATION | |
10 | 00850190004902 | 25171 | Long Obturator Cone | FLEX | MEDROBOTICS CORPORATION | |
11 | 00850190004896 | 25171 | Rectoscope, Body Short | FLEX | MEDROBOTICS CORPORATION | |
12 | 00850190004889 | 25171 | Rectoscope, Body Long | FLEX | MEDROBOTICS CORPORATION | |
13 | 00850190004865 | 26473 | TA Case Kit 4 | FLEX | MEDROBOTICS CORPORATION | |
14 | 00850190004858 | 26472 | TA Case Kit 3 | FLEX | MEDROBOTICS CORPORATION | |
15 | 00850190004841 | 26471 | TA Case Kit 2 | FLEX | MEDROBOTICS CORPORATION | |
16 | 00850190004834 | 26470 | TA Case Kit 1 | FLEX | MEDROBOTICS CORPORATION | |
17 | 00850190004827 | 26114 | Obturator, 4.5cm | FLEX | MEDROBOTICS CORPORATION | |
18 | 00850190004100 | 25171 | Flex Rectoscope | Flex | MEDROBOTICS CORPORATION | |
19 | 00850006222032 | GI EC-0412-1 | GI EC-0412-1 | Pathfinder® Endoscope Cap | NEPTUNE MEDICAL INC. | |
20 | 00840253114570 | FSC330-C6339-R | FSC330-C6339-R | Colonoscope | Fuse | ENDOCHOICE, INC. |
21 | 00840253114563 | FSC330-C6338-R | FSC330-C6338-R | Colonoscope | Fuse | ENDOCHOICE, INC. |
22 | 00840253114556 | FSC330-C6337-R | FSC330-C6337-R | Colonoscope | Fuse | ENDOCHOICE, INC. |
23 | 00840253114549 | FSC330-C6333-R | FSC330-C6333-R | Colonoscope | Fuse | ENDOCHOICE, INC. |
24 | 00840253114532 | FSC330-C6332-R | FSC330-C6332-R | Colonoscope | Fuse | ENDOCHOICE, INC. |
25 | 00840253114525 | FSC330-A6336-R | FSC330-A6336-R | Colonoscope | Fuse | ENDOCHOICE, INC. |
26 | 00840253114518 | FSC330-A6334-R | FSC330-A6334-R | Colonoscope | Fuse | ENDOCHOICE, INC. |
27 | 00840253114501 | FSC-3300-ST-R | FSC-3300-ST-R | Colonoscope | Fuse | ENDOCHOICE, INC. |
28 | 00840253114495 | FSC-3300-SL-R | FSC-3300-SL-R | Colonoscope | Fuse | ENDOCHOICE, INC. |
29 | 00840253114488 | FSC-3300-150-R | FSC-3300-150-R | Colonoscope | Fuse | ENDOCHOICE, INC. |
30 | 00840253114471 | FSC-3300-133-R | FSC-3300-133-R | Colonoscope | Fuse | ENDOCHOICE, INC. |
31 | 00840253114440 | FSC330-G7529-R | FSC330-G7529-R | Colonoscope | Fuse | ENDOCHOICE, INC. |
32 | 00840253114433 | FSC330-G7522-R | FSC330-G7522-R | Colonoscope | Fuse | ENDOCHOICE, INC. |
33 | 00840253114426 | FSC330-G7521-R | FSC330-G7521-R | Colonoscope | Fuse | ENDOCHOICE, INC. |
34 | 00840253114419 | FSC330-G7520-R | FSC330-G7520-R | Colonoscope | Fuse | ENDOCHOICE, INC. |
35 | 00840253114402 | FSC330-F7526-R | FSC330-F7526-R | Colonoscope | Fuse | ENDOCHOICE, INC. |
36 | 00840253114396 | FSC330-F7525-R | FSC330-F7525-R | Colonoscope | Fuse | ENDOCHOICE, INC. |
37 | 00840253114389 | FSC330-F7524-R | FSC330-F7524-R | Colonoscope | Fuse | ENDOCHOICE, INC. |
38 | 00840253114372 | FSC330-F7523-R | FSC330-F7523-R | Colonoscope | Fuse | ENDOCHOICE, INC. |
39 | 00840253111180 | SCT-469-02 | SCT-469-02 | Reusable Water Bottle with CO2 | Fuse | ENDOCHOICE, INC. |
40 | 00840253111173 | SCT-468-02 | SCT-468-02 | Reusable Water Bottle | Fuse | ENDOCHOICE, INC. |
41 | 00840253111128 | LS-FSC330-G7529 | Colonoscope | Fuse® | ENDOCHOICE, INC. | |
42 | 00840253111111 | LS-FSC330-G7522 | Colonoscope | Fuse® | ENDOCHOICE, INC. | |
43 | 00840253111104 | LS-FSC330-G7521 | Colonoscope | Fuse® | ENDOCHOICE, INC. | |
44 | 00840253111098 | LS-FSC330-G7520 | Colonoscope | Fuse® | ENDOCHOICE, INC. | |
45 | 00840253111081 | LS-FSC330-F7526 | Colonoscope | Fuse® | ENDOCHOICE, INC. | |
46 | 00840253111074 | LS-FSC330-F7525 | Colonoscope | Fuse® | ENDOCHOICE, INC. | |
47 | 00840253111067 | LS-FSC330-F7524 | Colonoscope | Fuse® | ENDOCHOICE, INC. | |
48 | 00840253111050 | LS-FSC330-F7523 | Colonoscope | Fuse® | ENDOCHOICE, INC. | |
49 | 00840253110831 | FDEMO-G7529 | Colonoscope | Fuse® | ENDOCHOICE, INC. | |
50 | 00840253110824 | FDEMO-G7522 | Colonoscope | Fuse® | ENDOCHOICE, INC. |