| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 05060359560209 | AB1 Instrument | 7-AB1-001 | The AB1 instrument, when used with the Creo Medical Electrosurgical System, is i The AB1 instrument, when used with the Creo Medical Electrosurgical System, is intended for use in coagulation (ablation) of soft tissue. 1.00 m long with a diameter of 2.00 mm | NEY | System, Ablation, Microwave And Accessories | 2 | Microblate Flex |
| 2 | 05060359560087 | Generator 7-EMR-050 | A mains electricity-powered (AC-powered) component of a microwave ablation/elect A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical system intended to generate both: 1) radio-frequency (RF) electrical current; and 2) microwave energy for subsequent cutting, coagulation, and ablation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues. It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery. | KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 2 | Creo Medical | |
| 3 | 05060359560063 | 7-RS2-210 | A non-patient-contact, insulated, electrical cord with a connector (plug) at bot A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. Some types may include an electrical isolator to prevent electrical shocks, and/or a cable cover. This is a single-use device. | KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 2 | Creo Medical | |
| 4 | 05060359560025 | 7-RS2-001 | 7-RS2-001 | A sterile, flexible, invasive, endoscopic device assembly intended to deliver: 1 A sterile, flexible, invasive, endoscopic device assembly intended to deliver: 1) a submucosal lifting solution; 2) an electrosurgical current in a bipolar configuration to tissues for cutting; and 3) microwave energy to tissues for coagulation. It is typically intended to treat gastrointestinal mucosal polyps/lesions through lifting of the diseased mucosa over a bubble of fluid, and subsequent electrosurgical excision of the diseased area. It includes a submucosal injection needle, an electrosurgical electrode, and a microwave tip, connected by a flexible sheath to a handpiece which includes controls (e.g., needle deployment control)/solution injection port. This is a single-use device. | KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | Creo Medical | |
| 5 | 05060359560292 | Croma Generator V4.0 | 7-EMR-050 | A mains electricity-powered (AC-powered) component of a microwave ablation/elect A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical system intended to generate both: 1) radio-frequency (RF) electrical current; and 2) microwave energy for subsequent cutting, coagulation, and ablation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues. It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery. | KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 2 | Croma |
| 6 | 05060359560223 | Slypseal Flex | 7-HS1-001 | HS1 is indicated for use in endoscopic injection therapy (to deliver pharmacolog HS1 is indicated for use in endoscopic injection therapy (to deliver pharmacological injection agents, such as vasoconstrictors) and endoscopic electrohemostasis (cauterization of tissue and coagulation of blood) of actual or potential bleeding sites in the gastrointestinal tract. These sites will include the following• Peptic Ulcers• Dieulafoy Lesions• Mallory-Weiss Tears• Bleeding Polyp Stalks• Arteriovenous Malformations (AVMs)• AngiomataThe HS1 also has irrigation capability. Any other use is not recommended. | KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | Croma | |
| 7 | 05060359560070 | Interface Cable | 7-RS2-210 | A non-patient-contact, insulated, electrical cord with a connector (plug) at bot A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. Some types may include an electrical isolator to prevent electrical shocks, and/or a cable cover. This is a single-use device. | KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 2 | Croma |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00724995180706 | 00711847 | 00711847 | The Bipolar Hemostatic Probe is passed through an endoscope's working channel to The Bipolar Hemostatic Probe is passed through an endoscope's working channel to provide hemostasis throughout the gastrointestinal tract. | NA | US ENDOSCOPY |
| 2 | 00724995180690 | 00711843 | 00711843 | The Bipolar Hemostatic Probe is passed through an endoscope's working channel to The Bipolar Hemostatic Probe is passed through an endoscope's working channel to provide hemostasis throughout the gastrointestinal tract. | NA | US ENDOSCOPY |
| 3 | 00724995180683 | 00711841 | 00711841 | The Bipolar Hemostatic Probe is passed through an endoscope's working channel to The Bipolar Hemostatic Probe is passed through an endoscope's working channel to provide hemostasis throughout the gastrointestinal tract. | NA | US ENDOSCOPY |
| 4 | 00724995180522 | 00711579 | 00711579 | The Torrent irrigation pump is used to provide irrigation in endoscopic procedur The Torrent irrigation pump is used to provide irrigation in endoscopic procedures. This product is used exclusively for our loaner program. | Torrent | US ENDOSCOPY |
| 5 | 00724995180515 | 00711569 | 00711569 | The Torrent irrigation pump is used to provide irrigation in endoscopic procedures. | Torrent | US ENDOSCOPY |
| 6 | 00653405051681 | 050054 | 050054 | APOLLO Papillotome | APOLLO | CONMED CORPORATION |
| 7 | 00653405051582 | 007107 | 007107 | APOLLO3 Papillotome, Triple Lumen, 20mm Tapered Tip/30mm Monofilament Cutting Wire | APOLLO3 | CONMED CORPORATION |
| 8 | 00653405051575 | 007106 | 007106 | APOLLO3 Papillotome, Triple Lumen, 20mm Tapered Tip/20mm Monofilament Cutting Wire | APOLLO3 | CONMED CORPORATION |
| 9 | 00653405051568 | 007105 | 007105 | APOLLO3 Papillotome, Triple Lumen, 8mm Tapered Tip/30mm Monofilament Cutting Wire | APOLLO3 | CONMED CORPORATION |
| 10 | 00653405051551 | 007104 | 007104 | APOLLO3 Papillotome, Triple Lumen, 8mm Tapered Tip/20mm Monofilament Cutting Wire | APOLLO3 | CONMED CORPORATION |
| 11 | 00191506008093 | M00553690 | M00553690 | Stent and Electrocautery - Enhanced Delivery System | Axios™ | BOSTON SCIENTIFIC CORPORATION |
| 12 | 00191506008086 | M00553680 | M00553680 | Stent and Electrocautery - Enhanced Delivery System | Axios™ | BOSTON SCIENTIFIC CORPORATION |
| 13 | 00191506006785 | M006D2201-0032 | M006D2201-0032 | Delivery Device | rezum | BOSTON SCIENTIFIC CORPORATION |
| 14 | 40653405014363 | 711B | 711B | GENERAL PURPOSE ELECTRODE 45 DEGREE ANGLE | NA | CONMED CORPORATION |
| 15 | 30653405014366 | 711B | 711B | GENERAL PURPOSE ELECTRODE 45 DEGREE ANGLE | NA | CONMED CORPORATION |
| 16 | M849G11200400 | G1120040 | 4581-U | An assembly of devices that uses radio-frequency (RF) alternating current to dev An assembly of devices that uses radio-frequency (RF) alternating current to develop heat directly within soft-tissue cells (thermodynamic) for cutting and coagulating tissue within a shield of argon (Ar) gas during surgery. It typically includes a generator, a single-use/reusable electrode handpiece with monopolar electrodes, connecting cables, foot-switch, and an argon gas supply system [housed in a separate trolley (cart) or incorporated into the system generator]. The current forms an ionized channel or arc within the argon shield which lessens the charring of tissue and provides rapid, uniform coagulation over large bleeding surfaces (e.g., capillary beds). | Hobbs Medical TouchSoft Coagulator | HOBBS MEDICAL, INC. |
| 17 | 20653405986451 | P2043F | P2043F | TruPass Papillotome with FX Wire | TruPass | CONMED CORPORATION |
| 18 | 20653405986444 | P2043A | P2043A | TruPass Papillotome with ACE Wire | TruPass | CONMED CORPORATION |
| 19 | 20653405986437 | P3043F | P3043F | TruPass Papillotome with FXWire | TruPass | CONMED CORPORATION |
| 20 | 20653405986420 | P3043A | P3043A | TruPass Papillotome with ACE Wire | TruPass | CONMED CORPORATION |
| 21 | 20653405051722 | 050063 | 050063 | APOLLO Papillotome, Double Lumen, 8mm Beveled Tip/20mm Monofilament Cutting Wire | APOLLO | CONMED CORPORATION |
| 22 | 20653405051715 | 050064 | 050064 | APOLLO Papillotome, Double Lumen, 8mm Beveled Tip/30mm Monofilament Cutting Wire | APOLLO | CONMED CORPORATION |
| 23 | 20653405051678 | 050053 | 050053 | APOLLO Papillotome, Double Lumen, 8mm Beveled Tip/20mm Braided Cutting Wire | APOLLO | CONMED CORPORATION |
| 24 | 20653405051661 | 007103 | 007103 | APOLLO Papillotome, Double Lumen, 20mm Tapered Tip/30mm Monofilament Cutting Wire | APOLLO | CONMED CORPORATION |
| 25 | 20653405051654 | 007102 | 007102 | APOLLO Papillotome, Double Lumen, 20mm Tapered Tip/20mm Monofilament Cutting Wire | APOLLO | CONMED CORPORATION |
| 26 | 20653405051647 | 007101 | 007101 | APOLLO Papillotome, Double Lumen, 8mm Tapered Tip/30mm Monofilament Cutting Wire | APOLLO | CONMED CORPORATION |
| 27 | 20653405051630 | 007100 | 007100 | APOLLO Papillotome, Double Lumen, 8mm Tapered Tip/20mm Monofilament Cutting Wire | APOLLO | CONMED CORPORATION |
| 28 | 20653405051623 | 7101AC | 7101AC | APOLLO AC PAPILLOTOME | APOLLO | CONMED CORPORATION |
| 29 | 20653405051616 | 7100AC | 7100AC | APOLLO AC PAPILLOTOME | APOLLO | CONMED CORPORATION |
| 30 | 20653405051609 | 050073 | 050073 | APOLLO PAPILLOTOME | APOLLO | CONMED CORPORATION |
| 31 | 20653405051593 | 050071 | 050071 | APOLLO PAPILLOTOME | APOLLO | CONMED CORPORATION |
| 32 | 20653405051548 | 7105AC | 7105AC | APOLLO AC PAPILLOTOME | APOLLO | CONMED CORPORATION |
| 33 | 20653405051531 | 7104AC | 7104AC | APOLLO AC PAPILLOTOME | APOLLO | CONMED CORPORATION |
| 34 | 14042761073971 | WA22539D | WA22539D | Olympus | OLYMPUS WINTER & IBE GMBH | |
| 35 | 14042761052518 | WA47055C | WA47055C | Olympus | OLYMPUS WINTER & IBE GMBH | |
| 36 | 14042761052501 | WA47054C | WA47054C | Olympus | OLYMPUS WINTER & IBE GMBH | |
| 37 | 14042761052488 | WA47053C | WA47053C | Olympus | OLYMPUS WINTER & IBE GMBH | |
| 38 | 14042761052464 | WA47052C | WA47052C | Olympus | OLYMPUS WINTER & IBE GMBH | |
| 39 | 14042761052440 | WA47051C | WA47051C | Olympus | OLYMPUS WINTER & IBE GMBH | |
| 40 | 14042761052426 | WA47050C | WA47050C | Olympus | OLYMPUS WINTER & IBE GMBH | |
| 41 | 14042761051603 | WA22039C | WA22039C | Olympus | OLYMPUS WINTER & IBE GMBH | |
| 42 | 14042761051580 | WA22038C | WA22038C | Olympus | OLYMPUS WINTER & IBE GMBH | |
| 43 | 14042761051566 | WA22037C | WA22037C | Olympus | OLYMPUS WINTER & IBE GMBH | |
| 44 | 14042761036860 | A22259C | A22259C | Olympus | OLYMPUS WINTER & IBE GMBH | |
| 45 | 14042761036853 | A22258C | A22258C | Olympus | OLYMPUS WINTER & IBE GMBH | |
| 46 | 14042761036839 | A22255C | A22255C | Olympus | OLYMPUS WINTER & IBE GMBH | |
| 47 | 14042761036822 | A22253C | A22253C | Olympus | OLYMPUS WINTER & IBE GMBH | |
| 48 | 14042761036815 | A22251C | A22251C | Olympus | OLYMPUS WINTER & IBE GMBH | |
| 49 | 14042761036785 | A22231D | A22231D | Olympus | OLYMPUS WINTER & IBE GMBH | |
| 50 | 14042761036778 | A22231C | A22231C | Olympus | OLYMPUS WINTER & IBE GMBH |