Address:253 Post Road W,Westport,CT,06880,US
Device Description : DiLumen consists of a soft flexible sheath that fits over standard colonoscopes. DiLumen consists of a soft flexible sheath that fits over standard colonoscopes. The device employs two balloons, one behind the bending section of the colonoscope and the second in front of the tip of the colonoscope. When both balloons are deployed, and inflated the area in between is stabilized. This Therapeutic Zone (TZ) facilitates stabilization, insufflation and manipulation of the tissue thus allowing the clinician to effectively treat the target area.
Device Class : 2
Duns Number: 859290897
Premarket Exempt : No
Prescription Use : Yes
Device Description : DiLumen C2 consists of a soft flexible sheath that fits over standard endoscopes DiLumen C2 consists of a soft flexible sheath that fits over standard endoscopes. The device employs two balloons, one behind the bending section of the endoscope and the second in front of the tip of the endoscope. When both balloons are deployed, and inflated the area in between is stabilized. This Therapeutic Zone (TZ) facilitates stabilization, insufflation and manipulation of the tissue thus allowing the clinician to effectively treat the target area. The device also has two flexible tool channels attached on the outside of the sleeve at the 3 and 6 o'clock positions. These tool channels accommodate flexible endoscopic instruments used to perform endoscopic interventions.
Device Class : 2
Duns Number: 859290897
Premarket Exempt : No
Prescription Use : Yes
Device Description : The DiLumen Endolumenal Interventional Grasper (“DiLumen Ig”) is a sterile, sing The DiLumen Endolumenal Interventional Grasper (“DiLumen Ig”) is a sterile, single use, disposable device intended to be used for grasping and manipulating tissue within the digestive tract under direct endoscopic visualization. The DiLumen Ig utilizes a pistol style handle, flexible 5mm shaft with an articulating section at the distal end and jaws that have DeBakey pattern teeth to allow one-handed operation for secure grasping and manipulation of tissue during endoscopic procedures. The DiLumen Ig handle incorporates controls that allow the user to rotate the shaft in a specific plane, rotate the jaws 360º, articulate the distal end of the shaft, open and close the jaws, and lock the articulation in a fixed position.
Device Class : 2
Duns Number: 859290897
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The DiLumen Is is a sterile, single patient use, disposable instrument that cons The DiLumen Is is a sterile, single patient use, disposable instrument that consists of a pistol style handle, a flexible 5mm shaft with an articulating section at the distal end, and scissor blades. The handle incorporates controls that enable one-handed operation of the device, including rotating the shaft; opening, closing and rotating the blades independently from the shaft; articulating the distal end of the shaft in a specific plane; and locking the articulation in a fixed position. The DiLumen Is has a plug at the bottom of the handle that can be used to connect the device to an electrosurgical generator via a dedicated cord. When the device is connected to the generator, monopolar current can be applied through the blades to cut or cauterize tissue electrosurgically
Device Class : 2
Duns Number: 859290897
Premarket Exempt : No
Prescription Use : Yes
Device Description : The DiLumen Is is a sterile, single patient use, disposable instrument that cons The DiLumen Is is a sterile, single patient use, disposable instrument that consists of a pistol style handle, a flexible 5mm shaft with an articulating section at the distal end, and scissor blades. The handle incorporates controls that enable one-handed operation of the device, including rotating the shaft; opening, closing and rotating the blades independently from the shaft; articulating the distal end of the shaft in a specific plane; and locking the articulation in a fixed position. The DiLumen Is has a plug at the bottom of the handle that can be used to connect the device to an electrosurgical generator via a dedicated cord. When the device is connected to the generator, monopolar current can be applied through the blades to cut or cauterize tissue electrosurgically
Device Class : 2
Duns Number: 859290897
Premarket Exempt : No
Prescription Use : Yes
Device Description : The DiLumen Endolumenal Interventional Grasper (“DiLumen Ig”) is a sterile, sing The DiLumen Endolumenal Interventional Grasper (“DiLumen Ig”) is a sterile, single use, disposable device intended to be used for grasping and manipulating tissue within the digestive tract under direct endoscopic visualization. The DiLumen Ig utilizes a pistol style handle, flexible 5mm shaft with an articulating section at the distal end and jaws that have DeBakey pattern teeth to allow one-handed operation for secure grasping and manipulation of tissue during endoscopic procedures. The DiLumen Ig handle incorporates controls that allow the user to rotate the shaft in a specific plane, rotate the jaws 360º, articulate the distal end of the shaft, open and close the jaws, and lock the articulation in a fixed position.
Device Class : 2
Duns Number: 859290897
Premarket Exempt : Yes
Prescription Use : Yes