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The stimulation lead incorporates a cuff segment that includes three electrodes in a guarded-bipolar configuration, which means the center electrode is connected to one pole of the stimulation (e.g., negative pole), and is flanked on each side by two electrodes connected to the opposite pole of stimulation (e.g., positive pole). It is packaged with a tunneling rod to facilitate the implant procedure. The cuff is surgically positioned around a patient’s hypoglossal nerve, and the connector end of the lead is connected to the IPG. The cuff electrodes apply electrical current that stimulates the nerve causing the tongue to move forward. The tongue movement (via genioglossus and other tongue protrusor muscle contraction) serves to maintain an open airway. The figure below provides an illustration of the Model 4063 stimulation lead.
Inspire Medical Systems, Inc.
900-001-007
In Commercial Distribution
- 10855728005182 ()
4063
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The stimulation lead incorporates a cuff segment that includes three electrodes in a guarded-bipolar configuration, which means the center electrode is connected to one pole of the stimulation (e.g., negative pole), and is flanked on each side by two electrodes connected to the opposite pole of stimulation (e.g., positive pole). It is packaged with a tunneling rod to facilitate the implant procedure. The cuff is surgically positioned around a patient’s hypoglossal nerve, and the connector end of the lead is connected to the IPG. The cuff electrodes apply electrical current that stimulates the nerve causing the tongue to move forward. The tongue movement (via genioglossus and other tongue protrusor muscle contraction) serves to maintain an open airway. The figure below provides an illustration of the Model 4063 stimulation lead.
Inspire Medical Systems, Inc.
900-001-011
In Commercial Distribution
- 10855728005809 ()
4063
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The stimulation lead incorporates a cuff segment that includes three electrodes in a guarded-bipolar configuration, which means the center electrode is connected to one pole of the stimulation (e.g., negative pole), and is flanked on each side by two electrodes connected to the opposite pole of stimulation (e.g., positive pole). It is packaged with a tunneling rod to facilitate the implant procedure. The cuff is surgically positioned around a patient’s hypoglossal nerve, and the connector end of the lead is connected to the IPG. The cuff electrodes apply electrical current that stimulates the nerve causing the tongue to move forward. The tongue movement (via genioglossus and other tongue protrusor muscle contraction) serves to maintain an open airway. The figure below provides an illustration of the Model 4063 stimulation lead.
Inspire Medical Systems, Inc.
900-001-010
In Commercial Distribution
- 10855728005670 ()
4063
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The stimulation lead incorporates a cuff segment that includes three electrodes in a guarded-bipolar configuration, which means the center electrode is connected to one pole of the stimulation (e.g., negative pole), and is flanked on each side by two electrodes connected to the opposite pole of stimulation (e.g., positive pole). It is packaged with a tunneling rod to facilitate the implant procedure. The cuff is surgically positioned around a patient’s hypoglossal nerve, and the connector end of the lead is connected to the IPG. The cuff electrodes apply electrical current that stimulates the nerve causing the tongue to move forward. The tongue movement (via genioglossus and other tongue protrusor muscle contraction) serves to maintain an open airway. The figure below provides an illustration of the Model 4063 stimulation lead.
Inspire Medical Systems, Inc.
900-001-009
In Commercial Distribution
- 10855728005533 ()
4063
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The stimulation lead incorporates a cuff segment that includes three electrodes in a guarded-bipolar configuration, which means the center electrode is connected to one pole of the stimulation (e.g., negative pole), and is flanked on each side by two electrodes connected to the opposite pole of stimulation (e.g., positive pole). It is packaged with a tunneling rod to facilitate the implant procedure. The cuff is surgically positioned around a patient’s hypoglossal nerve, and the connector end of the lead is connected to the IPG. The cuff electrodes apply electrical current that stimulates the nerve causing the tongue to move forward. The tongue movement (via genioglossus and other tongue protrusor muscle contraction) serves to maintain an open airway. The figure below provides an illustration of the Model 4063 stimulation lead.
Inspire Medical Systems, Inc.
900-001-008
In Commercial Distribution
- 10855728005397 ()
4063
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
Processes liquid based cytologic specimens to produce a uniform layer of cells on a glass microsope slide. It can also remove an aliquot from a specimen preserved in PreservCyt®.
Hologic, Inc.
ThinPrep Genesis Processor
In Commercial Distribution
- 15420045513860 ()
PRD-04573
- Microscope slide maker IVD
The Spatz3 Adjustable Balloon System is indicated for temporary use for weight loss in adults with obesity Body Mass Index (BMI) of 35.0-40.0 kg/m2 or a BMI of 30.0 to 34.9 kg/m2 with one or more major obesity-related comorbid conditions who have failed to achieve and maintain weight-loss with a supervised weight control program. The Spatz3 Adjustable Balloon System is to be used in conjunction with a long-term supervised diet and behavior modification program designed to increase the possibility of long-term weight-loss maintenance. The maximum placement period for Spatz3 Adjustable Balloon System is 8 months.
SPATZ FGIA (ISRAEL) LTD
A-SP3US-03K
In Commercial Distribution
- 00860005178803 ()
- Appetite-suppression gastric balloon
The Final Fit software receives the measured data from the Refractive Power/Corneal Analyzer OPD-Scan Model ARK-10000 via floppy disk etc. Then the Final Fit software performs a simulation of postoperative corneal shape and generates shot data using the imported data that was measured by the ARK-10000 and amounts of correction that are entered.
The Final Fit software has two major functions:
1.Generating shot data to be used with the EC-5000 based on the measured data of the ARK-10000
2.Comparing postoperative data measured by ARK-10000 with the preoperative or target data (Simulated data just before generating shot data)
NIDEK CO.,LTD.
1.12
In Commercial Distribution
- 04987669100042 ()
- Ophthalmic excimer laser system
The Final Fit software receives the measured data from the Refractive Power/Corneal Analyzer OPD-Scan Model ARK-10000 via floppy disk etc. Then the Final Fit software performs a simulation of postoperative corneal shape and generates shot data using the imported data that was measured by the ARK-10000 and amounts of correction that are entered.
The Final Fit software has two major functions:
1.Generating shot data to be used with the EC-5000 based on the measured data of the ARK-10000
2.Comparing postoperative data measured by ARK-10000 with the preoperative or target data (Simulated data just before generating shot data)
NIDEK CO.,LTD.
1.11US
In Commercial Distribution
- 04987669100035 ()
- Ophthalmic excimer laser system
The Final Fit software receives the measured data from the Refractive Power/Corneal Analyzer OPD-Scan Model ARK-10000 via floppy disk etc. Then the Final Fit software performs a simulation of postoperative corneal shape and generates shot data using the imported data that was measured by the ARK-10000 and amounts of correction that are entered. The Final Fit software has two major functions: 1.Generating shot data to be used with the EC-5000 based on the measured data of the ARK-10000 2.Comparing postoperative data measured by ARK-10000 with the preoperative or target data (Simulated data just before generating shot data)
NIDEK CO.,LTD.
1.13
In Commercial Distribution
- 04987669101346 ()
- Ophthalmic excimer laser system