Address:253 Post Road W,Westport,CT,06880,US
Device Description : The DiLumen Interventional Tool Mount ("DiLumen Im") is a dedicated accessory fo The DiLumen Interventional Tool Mount ("DiLumen Im") is a dedicated accessory for the DiLumen C2 that facilitates use of the DiLumen C2 tool channels by holding these channels in a fixed position. The Tool Mount consists of the FISSO Holding System with an added, permanently attached stainless steel tool bar to firmly hold the DiLumen C2 tool channels in the clinician’s preferred orientation. The Tool Mount and holding system is attached to a standard surgical table rail using a rail clamp.
Device Class : 1
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 : 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 Knife (“DiLumen Ik”) is a sterile, dispos The DiLumen Endolumenal Interventional Knife (“DiLumen Ik”) is a sterile, disposable monopolar electrosurgical device intended to be used for cutting, dissecting, and cauterizing tissue within the digestive tract during endoscopic procedures. The device is also indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions under direct endoscopic visualization. The DiLumen Ik utilizes a pistol style Handle, a Flexible Shaft with an articulating section at its distal end, and a stainless-steel Knife Tip that can be extended and retracted. The Handle incorporates controls that allow the clinician to rotate the Shaft, extend or retract the Knife Tip, articulate the distal end of the Shaft in a specific plane, and lock the articulation in a fixed position. There is also a female Luer Lock connector on the Handle that can be used with a standard luer lock syringe to introduce sterile saline at the distal end for flushing tissue debris from the knife tip or creating a bleb to lift mucosal lesions
Device Class : 2
Duns Number: 859290897
Premarket Exempt : No
Prescription Use : Yes
Device Description : The DiLumen Endolumenal Interventional Knife (“DiLumen Ik”) is a sterile, dispos The DiLumen Endolumenal Interventional Knife (“DiLumen Ik”) is a sterile, disposable monopolar electrosurgical device intended to be used for cutting, dissecting, and cauterizing tissue within the digestive tract during endoscopic procedures. The device is also indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions under direct endoscopic visualization. The DiLumen Ik utilizes a pistol style Handle, a Flexible Shaft with an articulating section at its distal end, and a stainless-steel Knife Tip that can be extended and retracted. The Handle incorporates controls that allow the clinician to rotate the Shaft, extend or retract the Knife Tip, articulate the distal end of the Shaft in a specific plane, and lock the articulation in a fixed position. There is also a female Luer Lock connector on the Handle that can be used with a standard luer lock syringe to introduce sterile saline at the distal end for flushing tissue debris from the knife tip or creating a bleb to lift mucosal lesions
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. This version DiLumen C2 is designed to work with the DiLumen Elbow Ig.
Device Class :
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. This DiLumen C2 version is designed to be used with the DiLumen Elbow Ig grasper.
Device Class :
Duns Number: 859290897
Premarket Exempt : No
Prescription Use : Yes
Device Description : 125 cm flexible shaft grasper with elbow bending section and articulating distal tip
Device Class : 2
Duns Number: 859290897
Premarket Exempt : Yes
Prescription Use : Yes
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 :
Duns Number: 859290897
Premarket Exempt : No
Prescription Use : Yes
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 :
Duns Number: 859290897
Premarket Exempt : No
Prescription Use : Yes