FCI S A S FCI 20 22

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Device Description : AUTOSTABLE BICANALICULUS INTUBATION SET II (25 MM) WITH DILATOR

Device Class : U

Duns Number: 763408366

Premarket Exempt : No

Product Code : OKS

Prescription Use : Yes

Device Count : 1

Device Description : AUTOSTABLE BICANALICULUS INTUBATION SET II (30 MM) WITH DILATOR

Device Class : U

Duns Number: 763408366

Premarket Exempt : No

Product Code : OKS

Prescription Use : Yes

Device Count : 1

Device Description : AUTOSTABLE BICANALICULUS INTUBATION SET II (35 MM) WITH DILATOR

Device Class : U

Duns Number: 763408366

Premarket Exempt : No

Product Code : OKS

Prescription Use : Yes

Device Count : 1

Device Description : BIKA® FOR DCR

Device Class : U

Duns Number: 763408366

Premarket Exempt : No

Product Code : OKS

Prescription Use : Yes

Device Count : 1

- Catalog Number : S1.1450u

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

Product Code : OKS

Prescription Use : Yes

Device Count : 3

- Catalog Number : S1.1490u

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

Product Code : OKS

Prescription Use : Yes

Device Count : 1

- Catalog Number : S1.1500

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

Product Code : OKS

Prescription Use : Yes

Device Count : 3

- Catalog Number : S1.1630

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

Product Code : OKS

Prescription Use : Yes

Device Count : 3

- Catalog Number : S1.1710

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

Product Code : OKS

Prescription Use : Yes

Device Count : 3

- Catalog Number : S1.1800u

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

Product Code : OKS

Prescription Use : Yes

Device Count : 3