Other products from "RESHAPE LIFESCIENCES INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00857334004248 1680 1680 The Model 1680 Torque Wrench is a sterile standard surgical wrench provided for The Model 1680 Torque Wrench is a sterile standard surgical wrench provided for use during the implant procedure to tighten the set screws that secure the leads to the Rechargeable Neuroregulator. PIM neuromodulator for obesity 3 Model 1680 Torque Wrench
2 00857334004309 2402 2402 The Model 2402 Mobile Charger (MC) is a non-sterile external component that is p The Model 2402 Mobile Charger (MC) is a non-sterile external component that is powered by a rechargeable, lithium-ion battery. The MC charges the Rechargeable Neuroregulator (RNR) when connected to a Transmit Coil positioned over the RNR. The MC also provides communication between the Clinician Programmer and RNR to allow up and down loading of data, display battery charge levels, indicate proper positioning of the Transmit Coil, alert patient to fault conditions, and allow for inactivation of therapy and turning off the RNR if needed. PIM neuromodulator for obesity 3 Model 2402 Maestro Mobile Charger
3 00857334004361 2504 2504 The Model 2504 Clinician Programmer Kit consists of a Model 2502 Clinician Progr The Model 2504 Clinician Programmer Kit consists of a Model 2502 Clinician Programmer, a Model 2402 Mobile Charger, a Model 2403-300 Clinician Transmit Coil, a Model 1620 AC Recharger, and a Model 1600 Programmer Cable that are packaged together. PIM neuromodulator for obesity 3 Model 2504 Maestro Clinician Programmer Kit
4 10850007764330 B-20301-10 B-20301-10 LAP-BAND Access Port Needle 3.5 inch Pouch LTI Implant, Intragastric For Morbid Obesity LAP-BAND® System Access Port Needle, 20G x 89 mm (3.5 in.)
5 00857334004347 2404 2404 The Model 2404 Patient Kit consists of a Model 2402 Mobile Charger, a Model 2403 The Model 2404 Patient Kit consists of a Model 2402 Mobile Charger, a Model 2403-60 Patient Transmit Coil, a Model 1620 AC Recharger, and a Model 1660 Patient Transmit Coil Belt that are packaged together. PIM neuromodulator for obesity 3 Model 2404 Maestro Patient Kit
6 00857334004316 2403-300 2403-300 The Model 2403-300 Transmit Coil is a non-sterile external component that is pla The Model 2403-300 Transmit Coil is a non-sterile external component that is placed within a standard sterile sleeve for use by a clinician in the operating room. The Transmit Coil is placed over the Rechargeable Neuroregulator (RNR) and attached to the Mobile Charger to provide a radio frequency link with the RNR for charging and communication. PIM neuromodulator for obesity 3 Model 2403-300 Maestro Clinician Transmit Coil
7 00857334004279 2004 2004 The Model 2004 Implant Kit consists of a Model 2002 Rechargeable Neuroregulator The Model 2004 Implant Kit consists of a Model 2002 Rechargeable Neuroregulator (including Model 1680 Torque Wrench), a Model 2200P-47E Maestro Posterior Lead, and a Model 2200A-47E Anterior Lead packaged together. PIM neuromodulator for obesity 3 Model 2004 Maestro Implant Kit
8 00850007764173 B-2017 B-2017 LAP-BAND System Calibration Tube KNT Tubes, Gastrointestinal (And Accessories) 3 LAP-BAND® System Calibration Tube
9 00850007764043 C-2304 C-2304 RapidPort EZ Access Port Kit (0-10cc) LTI Implant, Intragastric For Morbid Obesity 3 RapidPort® EZ Access Port Kit - 10cc
10 00857334004286 2200A-47E 2200A-47E The Model 2200A-47E Anterior Lead is provided sterile for implantation. It is a The Model 2200A-47E Anterior Lead is provided sterile for implantation. It is a flexible lead that contains bipolar platinum/iridium tip and ring electrodes with an insulated lead body. Electrical current is delivered to the tip electrode which is implanted to be in contact with the anterior trunk of the vagus nerve to block nerve signals. The ring electrode is placed in contact with the stomach to measure lead impedance. Sutures are used to anchor and stabilize the lead placement. The lead is connected to the implanted Rechargeable Neuroregulator. PIM neuromodulator for obesity 3 Model 2200A-47E Maestro Anterior Lead
11 00850007764067 C-2306 C-2306 RapidPort EZ Access Port Kit (0-14cc) LTI Implant, Intragastric For Morbid Obesity 3 RapidPort® EZ Access Port Kit - 14cc
12 10850007764323 B-20302-10 B-20302-10 LAP-BAND Access Port Needle 2 inch Pouch LTI Implant, Intragastric For Morbid Obesity LAP-BAND® System Access Port Needle, 20G x 51 mm (2 in.)
13 00857334004200 1620 1620 The Model 1620 AC Recharger is a non-sterile external power supply that connects The Model 1620 AC Recharger is a non-sterile external power supply that connects to a power outlet for use in charging the battery within the Mobile Charger. PIM neuromodulator for obesity 3 Model 1620 AC Recharger
14 00857334004262 2002 2002 The Model 2002 Rechargeable Neuroregulator (RNR) is provided sterile for implant The Model 2002 Rechargeable Neuroregulator (RNR) is provided sterile for implantation and has a hermetic case enclosure with an integrated coil that acts as an antenna for telemetry and recharging. The RNR is surgically implanted to deliver electrical current to the implanted leads. It contains a rechargeable battery which is charged transcutaneously using a Transmit Coil. PIM neuromodulator for obesity 3 Model 2002 Maestro Rechargeable Neuroregulator
15 00857334004217 1660 1660 The Model 1660 Patient Transmit Coil Belt is a non-sterile, optional external ac The Model 1660 Patient Transmit Coil Belt is a non-sterile, optional external accessory that may be used to assist in holding the Patient Transmit Coil over the location of the implanted Rechargeable Neuroregulator during charging. PIM neuromodulator for obesity 3 Model 1660 Maestro Patient Transmit Coil Belt
16 00850007764906 C-20390 C-20390 RapidPort EZ Applier Tool LTI Implant, Intragastric For Morbid Obesity 3 RapidPort® EZ Port Applier
17 00850007764203 B-2020 B-2020 Bio Gastric Balloon Suction Catheter KNT Tubes, Gastrointestinal (And Accessories) 2 Gastric Balloon Suction Catheter
18 00857334004354 2502 2502 The Model 2502 Clinician Programmer (CP) is a non-sterile external component tha The Model 2502 Clinician Programmer (CP) is a non-sterile external component that consists of a commercially available laptop computer configured with customized software. The CP connects to the Mobile Charger with a custom Programmer Cable. The CP enables the clinician to enter and modify therapy parameters and therapy schedule in the Rechargeable Neuroregulator. The graphical user interface of the CP allows the clinician to monitor system performance and patient compliance. The CP also provides access to the Instructions for Use manuals. PIM neuromodulator for obesity 3 Model 2502 Maestro Clinician Programmer
19 00857334004293 2200P-47E 2200P-47E The Model 2200P-47E Posterior Lead is provided sterile for implantation. It is a The Model 2200P-47E Posterior Lead is provided sterile for implantation. It is a flexible lead that contains bipolar platinum/iridium tip and ring electrodes with an insulated lead body. Electrical current is delivered to the tip electrode which is implanted to be in contact with the posterior trunk of the vagus nerve to block nerve signals. The ring electrode is placed in contact with the stomach to measure lead impedance. Sutures are used to anchor and stabilize the lead placement. The lead is connected to the implanted Rechargeable Neuroregulator. The Posterior Lead contains a white stripe along the lead body, a white suture tab, and a white coating on its' conductor cables to distinguish it from the Anterior Lead. PIM neuromodulator for obesity 3 Model 2200P-47E Maestro Posterior Lead
20 00857334004194 1600 1600 The Model 1600 Programmer Cable is a non-sterile external component that is used The Model 1600 Programmer Cable is a non-sterile external component that is used to provide connectivity between the Model 2502 Clinician Programmer and the Model 2402 Mobile Charger. PIM neuromodulator for obesity 3 Model 1600 Maestro Programmer Cable
21 00850007764609 C-2360 C-2360 The LAP-BAND AP Adjustable Gastric Banding System Standard with RapidPort EZ LTI Implant, Intragastric For Morbid Obesity 3 LAP-BAND AP® System Standard with RapidPort® EZ
22 00850007764234 B-2040 B-2040 Gastrointestinal Boundary Identification and Sizing Tube 40 French KNT Tubes, Gastrointestinal (And Accessories) 2 GIBI HD
23 00850007764210 B-2032 B-2032 Gastrointestinal Boundary Identification and Sizing Tube 32 French KNT Tubes, Gastrointestinal (And Accessories) 2 GIBI HD
24 00857334004323 2403-60 2403-60 The Model 2403-60 Transmit Coil is a non-sterile external component for use by t The Model 2403-60 Transmit Coil is a non-sterile external component for use by the patient. The Transmit Coil is placed over the Rechargeable Neuroregulator (RNR) and attached to the Mobile Charger to provide a radio frequency link with the RNR for charging and communication. PIM neuromodulator for obesity 3 Model 2403-60 Maestro Patient Transmit Coil
25 00850007764654 C-2365 C-2365 The LAP-BAND AP Adjustable Gastric Banding System Large with RapidPort EZ LTI Implant, Intragastric For Morbid Obesity 3 LAP-BAND AP® System Large with RapidPort® EZ
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No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
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18 00860110000303 2049 Work Inc. WORK INCORPORATED
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35 00859950007559 P1FTL8.0-EN Polyurethane Feeding Tube with male Enteral Connector 8.0Fr by 90cm NA FOOTPRINT MEDICAL, INC.
36 00859950007542 P1FTL6.5-EN Polyurethane Feeding Tube with male Enteral Connector 6.5Fr by 90cm NA FOOTPRINT MEDICAL, INC.
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40 00859950007504 P1FTM5.0-EN Polyurethane Feeding Tube with male Enteral Connector 5.0Fr by 60cm NA FOOTPRINT MEDICAL, INC.
41 00859950007498 P1FTM4.0-EN Polyurethane Feeding Tube with male Enteral Connector 4.0Fr by 60cm NA FOOTPRINT MEDICAL, INC.
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