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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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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
ENUCLEATION EVISCERATION IMPLANT Ø 12 MM
In Commercial Distribution

  • 03760087122435 ()

  • Outer Diameter: 12 Millimeter
S6.1012U

  • Orbital sphere implant
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
ePTFE BAND 2.1 X 5.5 mm
In Commercial Distribution

  • 03760087122428 ()

  • Length: 120 Millimeter
  • Width: 5.5 Millimeter
  • Height: 2.1 Millimeter
S5.4821U

  • Scleral buckling device, non-bioabsorbable
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
4 X 3 mm ePTFE SPONGE (CHAUVAUD)
In Commercial Distribution

  • 03760087122152 ()

  • Length: 120 Millimeter
  • Width: 4 Millimeter
  • Height: 3 Millimeter
S5.6670U

  • Scleral buckling device, non-bioabsorbable
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
9 mm ePTFE STRIP (DESIGNED BY O. LEQUOY)
In Commercial Distribution

  • 03760087122145 ()

  • Length: 90 Millimeter
  • Width: 7 Millimeter
  • Height: 2.22 Millimeter
S5.6660U

  • Scleral buckling device, non-bioabsorbable
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
ePTFE SPONGE 5 mm
In Commercial Distribution

  • 03760087122138 ()

  • Length: 90 Millimeter
  • Outer Diameter: 5 Millimeter
S5.6650U

  • Scleral buckling device, non-bioabsorbable
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
ePTFE HALF SPONGE 2.5 X 7.5 mm
In Commercial Distribution

  • 03760087122121 ()

  • Length: 120 Millimeter
  • Width: 7.5 Millimeter
  • Height: 2.5 Millimeter
S5.6645U

  • Scleral buckling device, non-bioabsorbable
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
ePTFE SPONGE 4 mm
In Commercial Distribution

  • 03760087122114 ()

  • Length: 90 Millimeter
  • Outer Diameter: 4 Millimeter
S5.6640U

  • Scleral buckling device, non-bioabsorbable
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
ePTFE SPONGE 3.0 X 5.0 mm
In Commercial Distribution

  • 03760087122091 ()

  • Length: 90 Millimeter
  • Width: 5 Millimeter
  • Height: 3 Millimeter
S5.6635U

  • Scleral buckling device, non-bioabsorbable
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
ePTFE SPONGE 3 mm
In Commercial Distribution

  • 03760087122084 ()

  • Length: 90 Millimeter
  • Outer Diameter: 3 Millimeter
S5.6630U

  • Scleral buckling device, non-bioabsorbable
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
ePTFE SPONGE 2 X 5 mm
In Commercial Distribution

  • 03760087122077 ()

  • Length: 90 Millimeter
  • Width: 5 Millimeter
  • Height: 2 Millimeter
S5.6625U

  • Scleral buckling device, non-bioabsorbable
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