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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 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 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.
Reshape Lifesciences Inc.
1680
Not in Commercial Distribution

  • 00857334004248 ()

  • Length: 1.685 Inch
  • Outer Diameter: 0.218 Inch
1680

  • Surgical torque wrench, reusable
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
SolarGen 2100s Holmium:YAG Laser Console
Artivion, Inc.
NS2000
In Commercial Distribution

  • 00877234000096 ()
LSR-SG2100S

  • Transmyocardial revascularization solid-state laser system
OCS Liver Gas Cylinder, Refill
TRANSMEDICS, INC.
3406
In Commercial Distribution

  • B00946653 ()
  • B00946650 ()

  • Length: 18 Inch
  • Width: 4 Inch
  • Height: 4 Inch
3406

  • Donor-organ preservation/transport system gas refillable cylinder
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