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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
STRIP (9.2 mm) TYPE 32
In Commercial Distribution

  • 53760087121235 ()
  • 03760087121230 ()

  • Length: 100 Millimeter
  • Width: 5 Millimeter
  • Height: 2.5 Millimeter
S5.1255U

  • 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
STRIP (7.2 mm) TYPE 31
In Commercial Distribution

  • 53760087121211 ()
  • 03760087121216 ()

  • Length: 100 Millimeter
  • Width: 4.5 Millimeter
  • Height: 2 Millimeter
S5.1205U

  • 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
STRIP (5.7 mm) TYPE 20
In Commercial Distribution

  • 53760087121198 ()
  • 03760087121193 ()

  • Length: 100 Millimeter
  • Width: 4 Millimeter
  • Height: 1.25 Millimeter
S5.1105U

  • 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
BAND (4.0 x 1.25 mm) TYPE 42
In Commercial Distribution

  • 53760087121181 ()
  • 03760087121186 ()

  • Length: 120 Millimeter
  • Width: 4.0 Millimeter
  • Height: 1.25 Millimeter
S5.1025U

  • 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
BAND (3.5 x 0.75 mm) TYPE 41
In Commercial Distribution

  • 53760087121174 ()
  • 03760087121179 ()
  • 33760087121170 ()

  • Length: 120 Millimeter
  • Width: 3.5 Millimeter
  • Height: 0.75 Millimeter
S5.1010

  • 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
BAND (2.0 x 0.75 mm) TYPE 40
In Commercial Distribution

  • 03760087121162 ()
  • 53760087121167 ()

  • Length: 120 Millimeter
  • Width: 2 Millimeter
  • Height: 0.75 Millimeter
S5.1005

  • Scleral buckling device, non-bioabsorbable
FCI directional LASER PROBE 23G QUANTEL
FCI S A S FCI 20 22
S9.1313.23
In Commercial Distribution

  • 23700773723373 ()
  • 03700773723379 ()


  • Ophthalmic laser system beam guide
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 BICONCAVE LENS
In Commercial Distribution

  • 53760087122218 ()
  • 03760087122213 ()

  • Angle: 36 degree
S5.7040U

  • Vitrectomy contact lens, single-use
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 12 TYPE 289
In Commercial Distribution

  • 53760087121433 ()
  • 03760087121438 ()

  • Width: 10 Millimeter
  • Outer Diameter: 33.2 Millimeter
  • Lumen/Inner Diameter: 25.4 Millimeter
S5.2325U

  • Scleral buckling device, non-bioabsorbable
100% SILICONE SILVER-HYDROGEL COATED FOLEY CATHETER, 30 CC, 2-WAY, 20 FR (6.7 MM)
Cardinal Health 200, LLC
630203IC
In Commercial Distribution

  • 50192253066379 ()
  • 20192253066378 ()
  • 10192253066371 ()
630203IC

  • Indwelling urethral drainage balloon catheter, non-antimicrobial
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