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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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Cervella Cranial Electrotherapy Stimulator (CES) system including noise-cancelling stereo headphones with integrated treatment electrodes. Cervella provides stimulation current intensity ranging from 50uA - 500uA in 50uA increments and user-selectable frequency presets of 0.5Hz, 1.5Hz, and 100Hz.
INNOVATIVE NEUROLOGICAL DEVICES LLC
Cervella CES
In Commercial Distribution

  • 00860001493306 ()
Cervella

  • Psychiatric/stress-therapy periauricular nerve transcutaneous electrical stimulation system
Plug
Coloplast A/S
9471S
In Commercial Distribution

  • 05708932987967 ()
9471S

  • Inflatable penile prosthesis
Titan Assembly Kit with Turbo™ Disposable Furlow Insertion Tool
Coloplast A/S
519190
Not in Commercial Distribution

  • 05708932661416 ()
519190

  • Inflatable penile prosthesis
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.
Reshape Lifesciences Inc.
2504
Not in Commercial Distribution

  • 00857334004361 ()
2504

  • 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 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.
Reshape Lifesciences Inc.
2403-60
Not in Commercial Distribution

  • 00857334004323 ()

  • Outer Diameter: 5 Inch
2403-60

  • Vagus nerve electrical stimulation system programmer
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 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
BioGlue Surgical Adhesive Applicator Tips
Artivion, Inc.
BGAT-SY
In Commercial Distribution

  • 10877234001182 ()
  • 00877234001185 ()
  • 20877234001189 ()

  • Length: 74.25 Millimeter
BGAT-SY

  • Open-surgery adhesive/sealant applicator, dual-channel
BioGlue Surgical Adhesive Delivery Tip Extension
Artivion, Inc.
BGDTE-10
In Commercial Distribution

  • 10877234000932 ()
  • 00877234000935 ()
  • 20877234000939 ()

  • Length: 10 Centimeter
BGDTE-10

  • Open-surgery adhesive/sealant applicator, dual-channel
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