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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.
Reshape Lifesciences Inc.
2004
Not in Commercial Distribution
- 00857334004279 ()
2004
- Gastric contractility modulation system
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.
Reshape Lifesciences Inc.
1660
Not in Commercial Distribution
- 00857334004217 ()
- Width: 2 Inch
- Length: 58 Inch
1660
- Electrical cable/lead holder
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.
Reshape Lifesciences Inc.
1600
Not in Commercial Distribution
- 00857334004194 ()
- Length: 60 Inch
1600
- Vagus nerve electrical stimulation system programmer
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.
Reshape Lifesciences Inc.
2502
Not in Commercial Distribution
- 00857334004354 ()
2502
- Vagus nerve electrical stimulation system programmer
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.
Reshape Lifesciences Inc.
2404
Not in Commercial Distribution
- 00857334004347 ()
2404
- Implant battery charger/performance analyser
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.
Reshape Lifesciences Inc.
2403-300
Not in Commercial Distribution
- 00857334004316 ()
- Outer Diameter: 5 Inch
2403-300
- Vagus nerve electrical stimulation system programmer
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.
Reshape Lifesciences Inc.
2200P-47E
Not in Commercial Distribution
- 00857334004293 ()
- Length: 47 Centimeter
2200P-47E
- Vagus nerve electrical stimulation system lead
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.
Reshape Lifesciences Inc.
2200A-47E
Not in Commercial Distribution
- 00857334004286 ()
- Length: 47 Centimeter
2200A-47E
- Vagus nerve electrical stimulation system lead
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.
Reshape Lifesciences Inc.
2002
Not in Commercial Distribution
- 00857334004262 ()
- Width: 86 Millimeter
- Height: 16 Millimeter
- Length: 71 Millimeter
2002
- Gastric contractility modulation system pulse generator
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.
Reshape Lifesciences Inc.
1620
Not in Commercial Distribution
- 00857334004200 ()
- Length: 9.5 Inch
1620
- Noninvasive device battery charger