Device Description : A collection of devices intended to be used to maintain patency of the nasolacri A collection of devices intended to be used to maintain patency of the nasolacrimal system typically for treating/preventing pathologies of the tear drainage system (e.g., post-chemotherapy stenosis) or after dacryocystorhinostomy (DCR). It consists of a long and flexible bicanalicular or monocanalicular tube (e.g., Crawford type) inserted through the lacrimal puncta into the canaliculi, lacrimal sac, and/or nasolacrimal duct; devices to assist the intubation procedure are typically provided preassembled to the tube (e.g., cannula, probes, bougies, introducer, stylet). The tube is typically left in place long-term before removal. This is a single-use device.
Device Class : U
Duns Number: 763408366
Premarket Exempt : No
Prescription Use : Yes
Device Description : A collection of devices intended to be used to maintain patency of the nasolacri A collection of devices intended to be used to maintain patency of the nasolacrimal system typically for treating/preventing pathologies of the tear drainage system (e.g., post-chemotherapy stenosis) or after dacryocystorhinostomy (DCR). It consists of a long and flexible bicanalicular or monocanalicular tube (e.g., Crawford type) inserted through the lacrimal puncta into the canaliculi, lacrimal sac, and/or nasolacrimal duct; devices to assist the intubation procedure are typically provided preassembled to the tube (e.g., cannula, probes, bougies, introducer, stylet). The tube is typically left in place long-term before removal. This is a single-use device.
Device Class : U
Duns Number: 763408366
Premarket Exempt : No
Prescription Use : Yes
Device Description : A collection of devices intended to be used to maintain patency of the nasolacri A collection of devices intended to be used to maintain patency of the nasolacrimal system typically for treating/preventing pathologies of the tear drainage system (e.g., post-chemotherapy stenosis) or after dacryocystorhinostomy (DCR). It consists of a long and flexible bicanalicular or monocanalicular tube (e.g., Crawford type) inserted through the lacrimal puncta into the canaliculi, lacrimal sac, and/or nasolacrimal duct; devices to assist the intubation procedure are typically provided preassembled to the tube (e.g., cannula, probes, bougies, introducer, stylet). The tube is typically left in place long-term before removal. This is a single-use device.
Device Class : U
Duns Number: 763408366
Premarket Exempt : No
Prescription Use : Yes
Device Description : SIZER FOR LACRIJET
Device Class : 1
Duns Number: 763408366
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : FCI directional LASER PROBE 23G QUANTEL
Device Class : 2
Duns Number: 763408366
Premarket Exempt : No
Prescription Use : No
Device Description : A sterile device inserted into a lacrimal punctum opening to prevent tear outflo A sterile device inserted into a lacrimal punctum opening to prevent tear outflow in dry eye patients. This is a single-use device.
Device Class : U
Duns Number: 763408366
Premarket Exempt : No
Prescription Use : Yes
Device Description : BIKA BICANALICULAR INTUBATION SET J.A. BERNARD, M.D.
Device Class : U
Duns Number: 763408366
Premarket Exempt : No
Prescription Use : Yes
Device Description : A sterile, implantable, single-lumen tube intended to provide tear drainage from A sterile, implantable, single-lumen tube intended to provide tear drainage from the front surface of the eye, typically into the nasal cavity or a paranasal sinus, as a drainage treatment for lacrimal canalicular pathologies in functional or obstructive epiphora; it may also be intended to facilitate saline solution irrigation to a paranasal sinus (e.g., ethmoid sinus) to manage chronic rhinosinusitis. Also referred to as a lacrimal stent, the device may be implanted after surgery to dilate or create a surgical passage [e.g., dacryocystostomy/dacryocystorhinostomy (DCR)], and is made of glass or synthetic polymer material(s) [e.g., silicone].
Device Class : U
Duns Number: 763408366
Premarket Exempt : No
Prescription Use : Yes
Device Description : A sterile, implantable, single-lumen tube intended to provide tear drainage from A sterile, implantable, single-lumen tube intended to provide tear drainage from the front surface of the eye, typically into the nasal cavity or a paranasal sinus, as a drainage treatment for lacrimal canalicular pathologies in functional or obstructive epiphora; it may also be intended to facilitate saline solution irrigation to a paranasal sinus (e.g., ethmoid sinus) to manage chronic rhinosinusitis. Also referred to as a lacrimal stent, the device may be implanted after surgery to dilate or create a surgical passage [e.g., dacryocystostomy/dacryocystorhinostomy (DCR)], and is made of glass or synthetic polymer material(s) [e.g., silicone].
Device Class : U
Duns Number: 763408366
Premarket Exempt : No
Prescription Use : Yes
Device Description : A sterile surgical instrument designed to accurately determine the depth of a re A sterile surgical instrument designed to accurately determine the depth of a recess (usually a drilled hole). It typically consists of a moveable (sliding) centerpiece (a prong), the tip of which is inserted into the recess; when the tip makes contact with the bottom a reading is visually taken from a scale marked on the side of the device. It is often used to measure the depth of holes being drilled in bone so that the surgeon can determine the length of the bone screw to be used. It is made of corrosive resistant materials [e.g., stainless steel, titanium (Ti), plastics]. This is a single-use device.
Device Class : 1
Duns Number: 763408366
Premarket Exempt : Yes
Prescription Use : Yes