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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 Ø 4 mm TYPE 504
In Commercial Distribution

  • 53760087121815 ()
  • 03760087121810 ()

  • Length: 100 Millimeter
  • Outer Diameter: 4 Millimeter
S5.6504U

  • 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
SPONGE Ø 3 mm TYPE 503
In Commercial Distribution

  • 53760087121808 ()
  • 03760087121803 ()

  • Length: 100 Millimeter
  • Outer Diameter: 3 Millimeter
S5.6503U

  • 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 DUCOURNAU BAND 2.5 X 7.0 mm
In Commercial Distribution

  • 03760087121674 ()

  • Length: 120 Millimeter
  • Width: 7 Millimeter
  • Height: 2.5 Millimeter
S5.4811U

  • 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 DUCOURNAU BAND 2.5 X 5.5 mm
In Commercial Distribution

  • 03760087121650 ()

  • Length: 120 Millimeter
  • Width: 5.5 Millimeter
  • Height: 2.44 Millimeter
S5.4801U

  • 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
FIXATION SLEEVE FOR S5.1025U TYPE 72
In Commercial Distribution

  • 53760087121556 ()
  • 03760087121551 ()

  • Length: 30 Millimeter
  • Outer Diameter: 2.41 Millimeter
  • Lumen/Inner Diameter: 1.57 Millimeter
S5.3025U

  • 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
FIXATION SLEEVE FOR S5.1015U TYPE 71
In Commercial Distribution

  • 53760087121549 ()
  • 03760087121544 ()

  • Length: 30 Millimeter
  • Outer Diameter: 2.16 Millimeter
  • Lumen/Inner Diameter: 1.02 Millimeter
S5.3515U

  • 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
FIXATION SLEEVE FOR S5.1005U TYPE 70
In Commercial Distribution

  • 53760087121525 ()
  • 03760087121520 ()

  • Length: 30 Millimeter
  • Outer Diameter: 2.16 Millimeter
  • Lumen/Inner Diameter: 1.02 Millimeter
S5.3005U

  • 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
ASYMMETRICAL TIRE 12 TYPE 280
In Commercial Distribution

  • 53760087121471 ()
  • 03760087121476 ()

  • Width: 10 Millimeter
  • Outer Diameter: 30 Millimeter
  • Lumen/Inner Diameter: 23.08 Millimeter
S5.2345U

  • 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
TIRE 11 TYPE 279
In Commercial Distribution

  • 53760087121457 ()
  • 03760087121452 ()

  • Width: 9 Millimeter
  • Outer Diameter: 31.23 Millimeter
S5.2335U

  • 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
BICONVEX TIRE 9 TYPE 287
In Commercial Distribution

  • 53760087121426 ()
  • 03760087121421 ()

  • Width: 7 Millimeter
  • Outer Diameter: 31.28 Millimeter
S5.2315U

  • Scleral buckling device, non-bioabsorbable
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