Address:8 Spring St,Stafford Springs,CT,06076,US
Device Description : A flexible tube used to extract or introduce non-drug fluids (e.g., saline solut A flexible tube used to extract or introduce non-drug fluids (e.g., saline solution) into body cavities other than the circulatory system (e.g., ears, wounds, urethra). It consists of a single lumen tube with end and/or side holes at the distal end; the proximal end is typically connected through a Luer-lock to a syringe or water pumping system. Dedicated devices are used for specific areas of the body (e.g., urinary tract, stomach, colon, uterus). This is a single-use device.
Device Class : 2
Duns Number: 076769355
Premarket Exempt : No
Prescription Use : Yes
Device Description : A flexible tube used to extract or introduce non-drug fluids (e.g., saline solut A flexible tube used to extract or introduce non-drug fluids (e.g., saline solution) into body cavities other than the circulatory system (e.g., ears, wounds, urethra). It consists of a single lumen tube with end and/or side holes at the distal end; the proximal end is typically connected through a Luer-lock to a syringe or water pumping system. Dedicated devices are used for specific areas of the body (e.g., urinary tract, stomach, colon, uterus). This is a single-use device.
Device Class : 2
Duns Number: 076769355
Premarket Exempt : No
Prescription Use : Yes
Device Description : A sterile, flexible tube intended to be used with an endoscope (e.g., colonoscop A sterile, flexible tube intended to be used with an endoscope (e.g., colonoscope) or bronchoscope to administer fluids (e.g., dyes for mucosal coloration) in spray form. The spray is produced by an atomizing nozzle at the distal end of the device. This is a single-use device.
Device Class : 2
Duns Number: 076769355
Premarket Exempt : No
Prescription Use : Yes
Device Description : A sterile, flexible tube intended to be used with an endoscope (e.g., colonoscop A sterile, flexible tube intended to be used with an endoscope (e.g., colonoscope) or bronchoscope to administer fluids (e.g., dyes for mucosal coloration) in spray form. The spray is produced by an atomizing nozzle at the distal end of the device. This is a single-use device.
Device Class : 2
Duns Number: 076769355
Premarket Exempt : No
Prescription Use : Yes
Device Description : A long, thin, flexible tube with an inflatable balloon at its distal tip used to A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically dilate gastrointestinal strictures. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device is multi-lumen with radiopaque markers and is wire-guided. This is a single-use device.
Device Class : 2
Duns Number: 076769355
Premarket Exempt : No
Prescription Use : Yes
Device Description : A long, thin, flexible tube with an inflatable balloon at its distal tip used to A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically dilate gastrointestinal strictures. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device is multi-lumen with radiopaque markers and is wire-guided. This is a single-use device.
Device Class : 2
Duns Number: 076769355
Premarket Exempt : No
Prescription Use : Yes
Device Description : A long, thin, flexible tube with an inflatable balloon at its distal tip used to A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically dilate gastrointestinal strictures. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device is multi-lumen with radiopaque markers and is wire-guided. This is a single-use device.
Device Class : 2
Duns Number: 076769355
Premarket Exempt : No
Prescription Use : Yes
Device Description : A long, thin, flexible tube with an inflatable balloon at its distal tip used to A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically dilate gastrointestinal strictures. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device is multi-lumen with radiopaque markers and is wire-guided. This is a single-use device.
Device Class : 2
Duns Number: 076769355
Premarket Exempt : No
Prescription Use : Yes
Device Description : A long, thin, flexible tube with an inflatable balloon at its distal tip used to A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically dilate gastrointestinal strictures. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device is multi-lumen with radiopaque markers and is wire-guided. This is a single-use device.
Device Class : 2
Duns Number: 076769355
Premarket Exempt : No
Prescription Use : Yes
Device Description : A long, thin, flexible tube with an inflatable balloon at its distal tip used to A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically dilate gastrointestinal strictures. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device is multi-lumen with radiopaque markers and is wire-guided. This is a single-use device.
Device Class : 2
Duns Number: 076769355
Premarket Exempt : No
Prescription Use : Yes