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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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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 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.
Reshape Lifesciences Inc.
2402
Not in Commercial Distribution

  • 00857334004309 ()

  • Width: 4.7 Inch
  • Height: 1.2 Inch
  • Length: 2 Inch
2402

  • Implant battery charger/performance analyser
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 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 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 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 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
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
No Description
Conmed Corporation
ZOLL SHORT
Not in Commercial Distribution

  • 00653405056198 ()


  • Pin-indexed adaptor, reusable
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