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, 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, 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, hand-held, manual, ophthalmic surgical instrument used for enlarging A sterile, hand-held, manual, ophthalmic surgical instrument used for enlarging the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. This is a single-use device.
Device Class : 1
Duns Number: 763408366
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : A sterile device inserted into a punctal opening to prevent tear outflow in dry A sterile device inserted into a punctal 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 : A sterile device inserted into a punctal opening to prevent tear outflow in dry A sterile device inserted into a punctal 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 : 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 device inserted into a punctal opening to prevent tear outflow in dry A sterile device inserted into a punctal 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