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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 sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buckling for the surgical treatment of retinal detachment. It is typically a moulded solid silicone or silicone sponge device available in a variety of shapes and sizes that is used to compress the retina long-term (up to months) to support its reattachment following the operative treatment of severe retinal detachment. This device, also known as a scleral buckling component, will occupy the intraocular space to provide compression against the retina so that it can reattach. It is typically removed after a period of time depending upon the clinical findings.
FCI S A S FCI 20 22
SPONGE 7.0 x 3.25 TYPE 907
Not in Commercial Distribution

  • 53760087127350 ()
  • 03760087127355 ()

  • Length: 100 Millimeter
  • Width: 7 Millimeter
  • Height: 3.25 Millimeter
S5.6585U

  • Scleral buckling device, non-bioabsorbable
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
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
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