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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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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.
FCI S A S FCI 20 22
S1.1540
In Commercial Distribution

  • 13760087123965 ()
  • 03760087123968 ()


  • Lacrimal intubation set
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.
FCI S A S FCI 20 22
S1.1535
In Commercial Distribution

  • 13760087123958 ()
  • 03760087123951 ()


  • Lacrimal intubation set
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.
FCI S A S FCI 20 22
S1.1530
In Commercial Distribution

  • 13760087123941 ()
  • 03760087123944 ()


  • Lacrimal intubation set
A rigid, ophthalmic surgical instrument with a sharp pyramidal or conical point used to puncture the eye to provide access to the interior of the eye for ophthalmic surgery. It is assembled and used together with a compatible cannula, filling its lumen and providing the necessary sharp point, thereby facilitating the introduction of this assembly. The trocar is withdrawn after puncturing, providing a working channel into the interior of the eye. It is typically available for use with an ophthalmic cannulation set. This is a reusable device.
FCI S A S FCI 20 22
RETILOCK® 23G VALVED SELF-RETAINING TROCAR
In Commercial Distribution

  • 53760087123888 ()
  • 03760087123883 ()

  • Needle Gauge: 23 Gauge
S9.7100.23

  • Ophthalmic cannula transscleral trocar blade
A rigid, ophthalmic surgical instrument with a sharp pyramidal or conical point used to puncture the eye to provide access to the interior of the eye for ophthalmic surgery. It is assembled and used together with a compatible cannula, filling its lumen and providing the necessary sharp point, thereby facilitating the introduction of this assembly. The trocar is withdrawn after puncturing, providing a working channel into the interior of the eye. It is typically available for use with an ophthalmic cannulation set. This is a reusable device.
FCI S A S FCI 20 22
RETILOCK® 23G NON VALVED SELF-RETAINING TROCAR
In Commercial Distribution

  • 53760087123871 ()
  • 03760087123876 ()

  • Needle Gauge: 23 Gauge
S9.7000.23

  • Ophthalmic cannula transscleral trocar blade
FCI NUNCHAKU 105
FCI S A S FCI 20 22
S1.1371
In Commercial Distribution

  • 13760087123743 ()
  • 03760087123746 ()


  • Lacrimal tube
FCI NUNCHAKU 90
FCI S A S FCI 20 22
S1.1361
In Commercial Distribution

  • 13760087123736 ()
  • 03760087123739 ()


  • Lacrimal tube
A device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a single-use device.
FCI S A S FCI 20 22
S6.3060
In Commercial Distribution

  • 13760087123712 ()
  • 03760087123715 ()


  • Surgical implant template, single-use
A sterile ophthalmic lens intended to be placed on the cornea of a patient to improve visualization of the fundus and retinal structures by surgical staff using an ophthalmic microscope during vitreoretinal surgery. Also known as a vitrectomy sutureless lens (VSL), it is made of various transparent materials [e.g., polymethylmethacrylate (PMMA), glass, quartz]. This is a single-use device.
FCI S A S FCI 20 22
DISPOSABLE PMMA AUTOSTABLE VITRECTOMY LENS, FLAT
In Commercial Distribution

  • 53760087123703 ()
  • 03760087123708 ()

  • Outer Diameter: 13 Millimeter
S5.8050U

  • Vitrectomy contact lens, single-use
A sterile ophthalmic lens intended to be placed on the cornea of a patient to improve visualization of the fundus and retinal structures by surgical staff using an ophthalmic microscope during vitreoretinal surgery. Also known as a vitrectomy sutureless lens (VSL), it is made of various transparent materials [e.g., polymethylmethacrylate (PMMA), glass, quartz]. This is a single-use device.
FCI S A S FCI 20 22
DISPOSABLE PMMA BICONCAVE LENS
In Commercial Distribution

  • 53760087123697 ()
  • 03760087123692 ()

  • Outer Diameter: 11.25 Millimeter
S5.8040U

  • Vitrectomy contact lens, single-use
A sterile ophthalmic lens intended to be placed on the cornea of a patient to improve visualization of the fundus and retinal structures by surgical staff using an ophthalmic microscope during vitreoretinal surgery. Also known as a vitrectomy sutureless lens (VSL), it is made of various transparent materials [e.g., polymethylmethacrylate (PMMA), glass, quartz]. This is a single-use device.
FCI S A S FCI 20 22
DISPOSABLE PMMA PRISMATIC 35° LENS
In Commercial Distribution

  • 53760087123680 ()
  • 03760087123685 ()

  • Outer Diameter: 11.25 Millimeter
S5.8030U

  • Vitrectomy contact lens, single-use
A sterile ophthalmic lens intended to be placed on the cornea of a patient to improve visualization of the fundus and retinal structures by surgical staff using an ophthalmic microscope during vitreoretinal surgery. Also known as a vitrectomy sutureless lens (VSL), it is made of various transparent materials [e.g., polymethylmethacrylate (PMMA), glass, quartz]. This is a single-use device.
FCI S A S FCI 20 22
DISPOSABLE PMMA VITRECTOMY LENS PLANOCONCAVE
In Commercial Distribution

  • 53760087123673 ()
  • 03760087123678 ()

  • Outer Diameter: 11.25 Millimeter
S5.8010U

  • Vitrectomy contact lens, single-use
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].
FCI S A S FCI 20 22
MASTERKA ® 40 (DESIGNER B. FAYET, M.D.)
In Commercial Distribution

  • 03760087123661 ()

  • Length: 40 Millimeter
  • Outer Diameter: 0.90 Millimeter
S1.1610

  • Lacrimal tube
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].
FCI S A S FCI 20 22
MASTERKA ® 35 (DESIGNER B. FAYET, M.D.)
In Commercial Distribution

  • 03760087123654 ()

  • Length: 35 Millimeter
  • Outer Diameter: 0.90 Millimeter
S1.1609

  • Lacrimal tube
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].
FCI S A S FCI 20 22
MASTERKA ® 30 (DESIGNER B. FAYET, M.D.)
In Commercial Distribution

  • 03760087123647 ()

  • Length: 30 Millimeter
  • Outer Diameter: 0.90 Millimeter
S1.1608

  • Lacrimal tube
An implantable ocular device designed to permanently fill the orbital cavity following enucleation, evisceration, or after the removal of another ocular implant (used as a secondary implant), to replace the volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis (the artificial eyeball). It is typically aspherical and may have porous surfaces to facilitate colonization by fibrovascular tissue to offer the advantages of reduced risk of infection or implant extrusion. It is available in various sizes and is typically made of polymethylmethacrylate (PMMA), poly 2-hydroxyethylmethacrylate (PHEMA), or silicone.
FCI S A S FCI 20 22
EGG SHAPED BIOCERAMIC ORBITAL IMPLANT DIA. 20 MM
In Commercial Distribution

  • 03760087123104 ()

  • Outer Diameter: 20 Millimeter
S6.5340U

  • Orbital sphere implant
An implantable ocular device designed to permanently fill the orbital cavity following enucleation, evisceration, or after the removal of another ocular implant (used as a secondary implant), to replace the volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis (the artificial eyeball). It is typically aspherical and may have porous surfaces to facilitate colonization by fibrovascular tissue to offer the advantages of reduced risk of infection or implant extrusion. It is available in various sizes and is typically made of polymethylmethacrylate (PMMA), poly 2-hydroxyethylmethacrylate (PHEMA), or silicone.
FCI S A S FCI 20 22
EGG SHAPED BIOCERAMIC ORBITAL IMPLANT DIA. 18 MM
In Commercial Distribution

  • 03760087123098 ()

  • Outer Diameter: 18 Millimeter
S6.5330U

  • Orbital sphere implant
An implantable ocular device designed to permanently fill the orbital cavity following enucleation, evisceration, or after the removal of another ocular implant (used as a secondary implant), to replace the volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis (the artificial eyeball). It is typically aspherical and may have porous surfaces to facilitate colonization by fibrovascular tissue to offer the advantages of reduced risk of infection or implant extrusion. It is available in various sizes and is typically made of polymethylmethacrylate (PMMA), poly 2-hydroxyethylmethacrylate (PHEMA), or silicone.
FCI S A S FCI 20 22
MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT (22 mm)
In Commercial Distribution

  • 03760087123081 ()

  • Outer Diameter: 22 Millimeter
S6.5322U

  • Orbital sphere implant
An implantable ocular device designed to permanently fill the orbital cavity following enucleation, evisceration, or after the removal of another ocular implant (used as a secondary implant), to replace the volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis (the artificial eyeball). It is typically aspherical and may have porous surfaces to facilitate colonization by fibrovascular tissue to offer the advantages of reduced risk of infection or implant extrusion. It is available in various sizes and is typically made of polymethylmethacrylate (PMMA), poly 2-hydroxyethylmethacrylate (PHEMA), or silicone.
FCI S A S FCI 20 22
MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT (20 mm)
In Commercial Distribution

  • 03760087123074 ()

  • Outer Diameter: 20 Millimeter
S6.5320U

  • Orbital sphere implant
An implantable ocular device designed to permanently fill the orbital cavity following enucleation, evisceration, or after the removal of another ocular implant (used as a secondary implant), to replace the volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis (the artificial eyeball). It is typically aspherical and may have porous surfaces to facilitate colonization by fibrovascular tissue to offer the advantages of reduced risk of infection or implant extrusion. It is available in various sizes and is typically made of polymethylmethacrylate (PMMA), poly 2-hydroxyethylmethacrylate (PHEMA), or silicone.
FCI S A S FCI 20 22
MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT (18 mm)
In Commercial Distribution

  • 03760087123067 ()

  • Outer Diameter: 18 Millimeter
S6.5318U

  • Orbital sphere implant
An implantable ocular device designed to permanently fill the orbital cavity following enucleation, evisceration, or after the removal of another ocular implant (used as a secondary implant), to replace the volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis (the artificial eyeball). It is typically aspherical and may have porous surfaces to facilitate colonization by fibrovascular tissue to offer the advantages of reduced risk of infection or implant extrusion. It is available in various sizes and is typically made of polymethylmethacrylate (PMMA), poly 2-hydroxyethylmethacrylate (PHEMA), or silicone.
FCI S A S FCI 20 22
MESH WRAPPED BIOCERAMIC ORBITAL IMPLANT (16 mm)
In Commercial Distribution

  • 03760087123050 ()

  • Outer Diameter: 16 Millimeter
S6.5316U

  • Orbital sphere implant
An implantable ocular device designed to permanently fill the orbital cavity following enucleation, evisceration, or after the removal of another ocular implant (used as a secondary implant), to replace the volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis (the artificial eyeball). It is typically aspherical and may have porous surfaces to facilitate colonization by fibrovascular tissue to offer the advantages of reduced risk of infection or implant extrusion. It is available in various sizes and is typically made of polymethylmethacrylate (PMMA), poly 2-hydroxyethylmethacrylate (PHEMA), or silicone.
FCI S A S FCI 20 22
BIOCERAMIC ORBITAL IMPLANT Ø 22 mm
In Commercial Distribution

  • 03760087122992 ()

  • Outer Diameter: 22 Millimeter
S6.5122U

  • Orbital sphere implant
An implantable ocular device designed to permanently fill the orbital cavity following enucleation, evisceration, or after the removal of another ocular implant (used as a secondary implant), to replace the volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis (the artificial eyeball). It is typically aspherical and may have porous surfaces to facilitate colonization by fibrovascular tissue to offer the advantages of reduced risk of infection or implant extrusion. It is available in various sizes and is typically made of polymethylmethacrylate (PMMA), poly 2-hydroxyethylmethacrylate (PHEMA), or silicone.
FCI S A S FCI 20 22
BIOCERAMIC ORBITAL IMPLANT Ø 21 mm
In Commercial Distribution

  • 03760087122985 ()

  • Outer Diameter: 21 Millimeter
S6.5121U

  • Orbital sphere implant
An implantable ocular device designed to permanently fill the orbital cavity following enucleation, evisceration, or after the removal of another ocular implant (used as a secondary implant), to replace the volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis (the artificial eyeball). It is typically aspherical and may have porous surfaces to facilitate colonization by fibrovascular tissue to offer the advantages of reduced risk of infection or implant extrusion. It is available in various sizes and is typically made of polymethylmethacrylate (PMMA), poly 2-hydroxyethylmethacrylate (PHEMA), or silicone.
FCI S A S FCI 20 22
BIOCERAMIC ORBITAL IMPLANT Ø 20 mm
In Commercial Distribution

  • 03760087122978 ()

  • Outer Diameter: 20 Millimeter
S6.5120U

  • Orbital sphere implant
An implantable ocular device designed to permanently fill the orbital cavity following enucleation, evisceration, or after the removal of another ocular implant (used as a secondary implant), to replace the volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis (the artificial eyeball). It is typically aspherical and may have porous surfaces to facilitate colonization by fibrovascular tissue to offer the advantages of reduced risk of infection or implant extrusion. It is available in various sizes and is typically made of polymethylmethacrylate (PMMA), poly 2-hydroxyethylmethacrylate (PHEMA), or silicone.
FCI S A S FCI 20 22
BIOCERAMIC ORBITAL IMPLANT Ø 19 mm
In Commercial Distribution

  • 03760087122961 ()

  • Outer Diameter: 19 Millimeter
S6.5119U

  • Orbital sphere implant
An implantable ocular device designed to permanently fill the orbital cavity following enucleation, evisceration, or after the removal of another ocular implant (used as a secondary implant), to replace the volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis (the artificial eyeball). It is typically aspherical and may have porous surfaces to facilitate colonization by fibrovascular tissue to offer the advantages of reduced risk of infection or implant extrusion. It is available in various sizes and is typically made of polymethylmethacrylate (PMMA), poly 2-hydroxyethylmethacrylate (PHEMA), or silicone.
FCI S A S FCI 20 22
BIOCERAMIC ORBITAL IMPLANT Ø 18 mm
In Commercial Distribution

  • 03760087122954 ()

  • Outer Diameter: 18 Millimeter
S6.5118U

  • Orbital sphere implant
An implantable ocular device designed to permanently fill the orbital cavity following enucleation, evisceration, or after the removal of another ocular implant (used as a secondary implant), to replace the volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis (the artificial eyeball). It is typically aspherical and may have porous surfaces to facilitate colonization by fibrovascular tissue to offer the advantages of reduced risk of infection or implant extrusion. It is available in various sizes and is typically made of polymethylmethacrylate (PMMA), poly 2-hydroxyethylmethacrylate (PHEMA), or silicone
FCI S A S FCI 20 22
BIOCERAMIC ORBITAL IMPLANT Ø 17 mm
In Commercial Distribution

  • 03760087122947 ()

  • Outer Diameter: 17 Millimeter
S6.5117U

  • Orbital sphere implant
An implantable ocular device designed to permanently fill the orbital cavity following enucleation, evisceration, or after the removal of another ocular implant (used as a secondary implant), to replace the volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis (the artificial eyeball). It is typically aspherical and may have porous surfaces to facilitate colonization by fibrovascular tissue to offer the advantages of reduced risk of infection or implant extrusion. It is available in various sizes and is typically made of polymethylmethacrylate (PMMA), poly 2-hydroxyethylmethacrylate (PHEMA), or silicone.
FCI S A S FCI 20 22
BIOCERAMIC ORBITAL IMPLANT Ø 16 mm
In Commercial Distribution

  • 03760087122930 ()

  • Outer Diameter: 16 Millimeter
S6.5116U

  • Orbital sphere implant
An implantable ocular device designed to permanently fill the orbital cavity following enucleation, evisceration, or after the removal of another ocular implant (used as a secondary implant), to replace the volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis (the artificial eyeball). It is typically aspherical and may have porous surfaces to facilitate colonization by fibrovascular tissue to offer the advantages of reduced risk of infection or implant extrusion. It is available in various sizes and is typically made of polymethylmethacrylate (PMMA), poly 2-hydroxyethylmethacrylate (PHEMA), or silicone.
FCI S A S FCI 20 22
BIOCERAMIC ORBITAL IMPLANT Ø 14 mm
In Commercial Distribution

  • 03760087122923 ()

  • Outer Diameter: 14 Millimeter


  • Orbital sphere implant
An implantable ocular device designed to permanently fill the orbital cavity following enucleation, evisceration, or after the removal of another ocular implant (used as a secondary implant), to replace the volume and possibly, given the surgical method, to impart motion to the eventual ocular prosthesis (the artificial eyeball). It is typically aspherical and may have porous surfaces to facilitate colonization by fibrovascular tissue to offer the advantages of reduced risk of infection or implant extrusion. It is available in various sizes and is typically made of polymethylmethacrylate (PMMA), poly 2-hydroxyethylmethacrylate (PHEMA), or silicone.
FCI S A S FCI 20 22
BIOCERAMIC ORBITAL IMPLANT Ø 12 mm
In Commercial Distribution

  • 03760087122916 ()

  • Outer Diameter: 12 Millimeter
S6.5112U

  • Orbital sphere implant
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