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The Inspire® Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea. The lead features a flexible, self-sizing cuff. Electrodes in the inner surface of the cuff deliver stimulation to the nerve. The lead incorporates a standard connector for coupling to the Inspire implantable pulse generator (IPG).
Inspire Medical Systems, Inc.
900-013-001
In Commercial Distribution
- 10855728005793 ()
4340
- Implantable sleep apnoea treatment system, respiration-sensing
The Inspire® Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea. The lead features a flexible, self-sizing cuff. Electrodes in the inner surface of the cuff deliver stimulation to the nerve. The lead incorporates a standard connector for coupling to the Inspire implantable pulse generator (IPG).
Inspire Medical Systems, Inc.
900-013-001
Not in Commercial Distribution
- 00855728005796 ()
4340
- Implantable sleep apnoea treatment system, respiration-sensing
Coseal Surgical Sealant (Coseal) is composed of two synthetic polyethylene glycols (PEGs), a dilute hydrogen chloride solution and a sodium phosphate/sodium carbonate solution. These components come in a kit that includes an applicator(s). At the time of administration, the mixed PEGs and solutions form a hydrogel that adheres to tissue, synthetic graft materials and covalently bonds to itself
BAXTER HEALTHCARE CORPORATION
934072
In Commercial Distribution
- 05413765404634 ()
- Total Volume: 8 Milliliter
934072
- Surgical internal adhesive/sealant, synthetic polymer
Coseal Surgical Sealant (Coseal) is composed of two synthetic polyethylene glycols (PEGs), a dilute hydrogen chloride solution and a sodium phosphate/sodium carbonate solution. These components come in a kit that includes an applicator(s). At the time of administration, the mixed PEGs and solutions form a hydrogel that adheres to tissue, synthetic graft materials and covalently bonds to itself
BAXTER HEALTHCARE CORPORATION
934071
In Commercial Distribution
- 05413765404627 ()
- Total Volume: 4 Milliliter
934071
- Surgical internal adhesive/sealant, synthetic polymer
Coseal Surgical Sealant (Coseal) is composed of two synthetic polyethylene glycols (PEGs), a dilute hydrogen chloride solution and a sodium phosphate/sodium carbonate solution. These components come in a kit that includes an applicator(s). At the time of administration, the mixed PEGs and solutions form a hydrogel that adheres to tissue, synthetic graft materials and covalently bonds to itself
BAXTER HEALTHCARE CORPORATION
934070
In Commercial Distribution
- 05413765404610 ()
- Total Volume: 2 Milliliter
934070
- Surgical internal adhesive/sealant, synthetic polymer
Nitric oxide (NO) is generated by the LungFit PH from room air just prior to delivery into an attached
breathing circuit. The device also incorporates a gas monitoring system (with user-set alarms) for measuring the gas concentrations of nitric oxide,
nitrogen dioxide (NO2) and oxygen (O2) in the breathing circuit just prior to inhalation by the patient, via a sampling line.
Beyond Air, Inc.
80013
In Commercial Distribution
- B882800130 ()
- Nitric oxide delivery unit, system-based
Nitric oxide (NO) is generated by the LungFit PH from room air just prior to delivery into an attached
breathing circuit. The device also incorporates a gas monitoring system (with user-set alarms) for measuring the gas concentrations of nitric oxide,
nitrogen dioxide (NO2) and oxygen (O2) in the breathing circuit just prior to inhalation by the patient, via a sampling line.
Beyond Air, Inc.
80012
In Commercial Distribution
- B882800120 ()
- Nitric oxide delivery unit, system-based
The intended purpose of the Fixture Removal kit is, by an Integrum certified physician, to perform the removal of a Femur Fixture.
Consist of instruments:
Mounting Tool for Trephine
Guide Pins
Fixture Mount Screw
Fixture Mount
Hammer
Hammer Handle
Fixture Mount Connector
Fixture Mount Connector Screw
Fixture Mount Handle
Spanner 8 mm
Spanner 12 mm
Spanner 14 mm
Spanner 19 mm
Integrum AB
2532
In Commercial Distribution
- 07340152102034 ()
- Internal-external leg prosthesis osseointegration bar
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
The therascreen FGFR RGQ RT-PCR Kit is a real-time, reverse transcription PCR test for the qualitative detection of two point mutations in exon 7 [p.R248C (c.742C>T), p.S249C (c.746C>G)], two point mutations in exon 10 [p.G370C (c.1108G>T) and p.Y373C (c.1118A>G)] and two fusions (FGFR3-TACC3v1 and FGFR3-TACC3v3) in the fibroblast growth factor receptor 3 (FGFR3) gene in RNA samples derived from formalin-fixed paraffin-embedded (FFPE) urothelial tumor tissue. The test is indicated for use as an aid in identifying patients with cases of urothelial cancer (UC) which harbor these alterations and are therefore eligible for treatment with BALVERSA™ (erdafitinib).
Specimens are processed using the RNeasy DSP FFPE Kit for manual sample preparation followed by reverse transcription and then automated amplification and detection on the Rotor-Gene Q MDx (US) instrument.
QIAGEN GmbH
2
In Commercial Distribution
- 04053228043560 ()
874721
- Fibroblast growth factor receptor (FGFR) gene mutation IVD, kit, nucleic acid technique (NAT)