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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 Gas Sampling Line (p/n 90031) delivers a gas sample of the ventilator gas flow to the monitoring system in the LungFit PH. The gas sampling line has a male Luer lock connector at each end that is attached at one end to the inspiratory limb of the ventilator breathing circuit via the sample T adaptor (with a female Luer lock connector), near the patient connection and to the LungFit PH System female Leur Lock connector gas sampling port at the other end. The gas sample line is composed of a 12 inch length of Nafion tubing for removing moisture from the sample gas, a gas sample tube with Leur fittings and a hydrophobic filter to prevent any remaining water in the sample gas from entering the LungFit PH.
Beyond Air, Inc.
90031
In Commercial Distribution
- B882900310 ()
- B882900311 ()
- B882900312 ()
- Nitric oxide delivery unit, system-based
Revanesse® Lips+ is manufactured by Prollenium Medical Technologies, and is a biocompatible, biodegradable, non-pyrogenic, sterile, injectable viscoelastic clear
colorless hydrogel based on bioresorbable BDDE cross-linked hyaluronan (HA) (22 – 28 mg / mL concentration) containing 0.3% lidocaine. The HA is produced by the
Streptococcus species of bacteria. The gel is delivered in a pre-filled disposable glass syringe. Each syringe is fitted with a Luer lock adaptor, a plunger rod, a rubber stopper tip cap, and a finger grip. Each box of Revanesse® Lips+ contains two 1.2 mL syringes of Revanesse® Lips+ along with two 0.5-inch 30-gauge sterile needles. The syringe is labeled with the product name, the manufacturer, lot number, and expiration date. There is a removable portion of the label, which can be affixed to the patient record.
Prollenium Medical
40149
In Commercial Distribution
- 10669808003032 ()
- Dermal tissue reconstructive material, microbe-derived, anaesthetic
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
Cardiac resynchronization device, tiered-therapy cardioverter/defibrillator VVED DDDRV
ST. JUDE MEDICAL, INC.
CD3365-40QC
In Commercial Distribution
- 05414734508285 ()
CD3365-40QC
- Cardiac resynchronization therapy implantable defibrillator
Cardiac resynchronization device, tiered-therapy cardioverter/defibrillator VVED DDDRV
ST. JUDE MEDICAL, INC.
CD3357-40QC
In Commercial Distribution
- 05414734508209 ()
- Total Volume: 36 Milliliter
CD3357-40QC
- Cardiac resynchronization therapy implantable defibrillator