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A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical system intended to generate both: 1) radio-frequency (RF) electrical current; and 2) microwave energy for subsequent cutting, coagulation, and ablation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues. It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery.
CREO MEDICAL LIMITED
Croma Generator V4.0
7-EMR-050
- Microwave/electrosurgical system generator
A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical system intended to generate both: 1) radio-frequency (RF) electrical current; and 2) microwave energy for subsequent cutting, coagulation, and ablation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues. It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery.
CREO MEDICAL LIMITED
Generator 7-EMR-050 with Footswitch 2-EMR-050
Not in Commercial Distribution
- 05060359560124 ()
- Microwave/electrosurgical system generator
A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical system intended to generate both: 1) radio-frequency (RF) electrical current; and 2) microwave energy for subsequent cutting, coagulation, and ablation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues. It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery.
CREO MEDICAL LIMITED
Generator 7-EMR-050
Not in Commercial Distribution
- 05060359560087 ()
- Microwave/electrosurgical system generator
A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. Some types may include an electrical isolator to prevent electrical shocks, and/or a cable cover. This is a single-use device.
CREO MEDICAL LIMITED
Interface Cable
In Commercial Distribution
- 05060359560070 ()
7-RS2-210
- Electrical-only medical device connection cable, single-use
A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. Some types may include an electrical isolator to prevent electrical shocks, and/or a cable cover. This is a single-use device.
CREO MEDICAL LIMITED
7-RS2-210
In Commercial Distribution
- 05060359560063 ()
- Electrical-only medical device connection cable, single-use
A sterile, flexible, invasive, endoscopic device assembly intended to deliver: 1) a submucosal lifting solution; 2) an electrosurgical current in a bipolar configuration to tissues for cutting; and 3) microwave energy to tissues for coagulation. It is typically intended to treat gastrointestinal mucosal polyps/lesions through lifting of the diseased mucosa over a bubble of fluid, and subsequent electrosurgical excision of the diseased area. It includes a submucosal injection needle, an electrosurgical electrode, and a microwave tip, connected by a flexible sheath to a handpiece which includes controls (e.g., needle deployment control)/solution injection port. This is a single-use device.
CREO MEDICAL LIMITED
7-RS2-001
In Commercial Distribution
- 05060359560025 ()
- 05060359560049 ()
- Outer Diameter: 3.7 Millimeter
- Catheter Length: 2.3 Meter
7-RS2-001
- Endoscopic electrosurgical/microwave submucosal lift/resection instrument
MON 2490C15 CL 60601 3 ED HCM USA RFB
MEDTRONIC, INC.
2490C15
Not in Commercial Distribution
- 00643169341050 ()
- Cardiac pulse generator reader, home-use
An electronic device designed to calculate nasal resistance by measuring nasal airflow and the air pressure producing that flow within a patient's nasal passages, e.g., for the calculation of the nasal patency during ear/nose/throat (ENT) assessment/treatment. It is used to quantify the amount of nasal obstruction/congestion and is a computer-based device with dedicated software for data calculation, presentation (display), and storage purposes. This device will be powered via a connected computer and include or interface with a printer for hard copies of the graphical data presentation.
GM INSTRUMENTS LIMITED
NR6
In Commercial Distribution
- 05060485270034 ()
N/A
- Computerized rhinomanometer
A line powered (AC- powered), or powered via a connected computer, electronic device designed to allow the internal profile of the nose to be recorded in order to quantify the degree of obstruction/congestion in the nasal cavities and provide monitoring of the consequences of therapy or surgery.
A nosepiece conducts a sound pulse produced by an integrated sound generator to the patient's nose and the sound reflections from the nose are detected where changes in cross-sectional areas are encountered. It is a computer-based device with dedicated software for processing the output and return signals to produce plots of cross-sectional areas as a function of distance in the nose.
GM INSTRUMENTS LIMITED
A1
In Commercial Distribution
- 05060485270027 ()
N/A
- Acoustic rhinometer
Phagenyx Dysphagia Treatment Device
PHAGENESIS LIMITED
EPSB3
In Commercial Distribution
- 05060453480045 ()
EPSB3
- Pharyngeal electrical stimulation control unit