Address:8 Spring St,Stafford Springs,CT,06076,US
Device Description : A sterile non-bioabsorbable tubular device intended to be implanted in an obstru A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed pancreatic duct (e.g., due to stricture or malignancy) to maintain luminal patency; it may also be intended to treat a wide variety of conditions in pancreatic endoscopy (e.g., drain pseudocyst, treat fistula or duct disruption). It is made entirely of a synthetic polymer and has a continuous tube design with or without retention flanges. This is a single-use device.
Device Class : 2
Duns Number: 076769355
Premarket Exempt : No
Prescription Use : Yes
Device Description : A sterile non-bioabsorbable tubular device intended to be implanted in an obstru A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed pancreatic duct (e.g., due to stricture or malignancy) to maintain luminal patency; it may also be intended to treat a wide variety of conditions in pancreatic endoscopy (e.g., drain pseudocyst, treat fistula or duct disruption). It is made entirely of a synthetic polymer and has a continuous tube design with or without retention flanges. This is a single-use device.
Device Class : 2
Duns Number: 076769355
Premarket Exempt : No
Prescription Use : Yes
Device Description : A sterile non-bioabsorbable tubular device intended to be implanted in an obstru A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed pancreatic duct (e.g., due to stricture or malignancy) to maintain luminal patency; it may also be intended to treat a wide variety of conditions in pancreatic endoscopy (e.g., drain pseudocyst, treat fistula or duct disruption). It is made entirely of a synthetic polymer and has a continuous tube design with or without retention flanges. This is a single-use device.
Device Class : 2
Duns Number: 076769355
Premarket Exempt : No
Prescription Use : Yes
Device Description : A sterile non-bioabsorbable tubular device intended to be implanted in an obstru A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed pancreatic duct (e.g., due to stricture or malignancy) to maintain luminal patency; it may also be intended to treat a wide variety of conditions in pancreatic endoscopy (e.g., drain pseudocyst, treat fistula or duct disruption). It is made entirely of a synthetic polymer and has a continuous tube design with or without retention flanges. This is a single-use device.
Device Class : 2
Duns Number: 076769355
Premarket Exempt : No
Prescription Use : Yes
Device Description : A sterile non-bioabsorbable tubular device intended to be implanted in an obstru A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed pancreatic duct (e.g., due to stricture or malignancy) to maintain luminal patency; it may also be intended to treat a wide variety of conditions in pancreatic endoscopy (e.g., drain pseudocyst, treat fistula or duct disruption). It is made entirely of a synthetic polymer and has a continuous tube design with or without retention flanges. This is a single-use device.
Device Class : 2
Duns Number: 076769355
Premarket Exempt : No
Prescription Use : Yes
Device Description : A sterile non-bioabsorbable tubular device intended to be implanted in an obstru A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed pancreatic duct (e.g., due to stricture or malignancy) to maintain luminal patency; it may also be intended to treat a wide variety of conditions in pancreatic endoscopy (e.g., drain pseudocyst, treat fistula or duct disruption). It is made entirely of a synthetic polymer and has a continuous tube design with or without retention flanges. This is a single-use device.
Device Class : 2
Duns Number: 076769355
Premarket Exempt : No
Prescription Use : Yes
Device Description : A sterile non-bioabsorbable tubular device intended to be implanted in an obstru A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed pancreatic duct (e.g., due to stricture or malignancy) to maintain luminal patency; it may also be intended to treat a wide variety of conditions in pancreatic endoscopy (e.g., drain pseudocyst, treat fistula or duct disruption). It is made entirely of a synthetic polymer and has a continuous tube design with or without retention flanges. This is a single-use device.
Device Class : 2
Duns Number: 076769355
Premarket Exempt : No
Prescription Use : Yes
Device Description : A flexible device intended to be inserted through an endoscope to ligate, cauter A flexible device intended to be inserted through an endoscope to ligate, cauterize, and cut polyps, or other mucosal lesions in the gastrointestinal (GI) tract, using high frequency current during endotherapy. It consists of a flexible insulated insertion sheath, a snare loop attached to the distal end of the sheath, and an operating wire connected to both the loop and a handle which controls the operating wire. The proximal end of the operating wire is connected to a high frequency power supply unit. This is a single use device.
Device Class : 2
Duns Number: 076769355
Premarket Exempt : No
Prescription Use : Yes
Device Description : An assembly of devices that uses radio-frequency (RF) alternating current to dev An assembly of devices that uses radio-frequency (RF) alternating current to develop heat directly within soft-tissue cells (thermodynamic) for cutting and coagulating tissue within a shield of argon (Ar) gas during surgery. It typically includes a generator, a single-use/reusable electrode handpiece with monopolar electrodes, connecting cables, foot-switch, and an argon gas supply system [housed in a separate trolley (cart) or incorporated into the system generator]. The current forms an ionized channel or arc within the argon shield which lessens the charring of tissue and provides rapid, uniform coagulation over large bleeding surfaces (e.g., capillary beds).
Device Class : 2
Duns Number: 076769355
Premarket Exempt : Yes
Prescription Use : Yes