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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
An ophthalmic device that is implanted subcutaneously within the upper eyelid to "lidload" the eyelid to restore upper eyelid muscle (musculus orbicularis oculi) function. This device is used for the treatment of lagophthalmos, a condition that frequently results from facial paralysis caused by Bell's palsy, trauma, a stroke, or as an indirect consequence of the surgical removal of certain types of tumour in close proximity to the facial nerve. This device uses gravity to gently close the upper eyelid when blinking or when the eyelid muscle is relaxed, and is made of a heavy material [e.g., gold (Au), platinum (Pt)].
FCI S A S FCI 20 22
PTOSE-UP 2 mm WIDTH J.M. RUBAN M.D.
In Commercial Distribution

  • 03760087120806 ()

  • Length: 150 Millimeter
S3.3021u

  • Eyelid weight, implantable
An ophthalmic device that is implanted subcutaneously within the upper eyelid to "lidload" the eyelid to restore upper eyelid muscle (musculus orbicularis oculi) function. This device is used for the treatment of lagophthalmos, a condition that frequently results from facial paralysis caused by Bell's palsy, trauma, a stroke, or as an indirect consequence of the surgical removal of certain types of tumour in close proximity to the facial nerve. This device uses gravity to gently close the upper eyelid when blinking or when the eyelid muscle is relaxed, and is made of a heavy material [e.g., gold (Au), platinum (Pt)].
FCI S A S FCI 20 22
PTOSE-UP 3 mm WIDTH J.M. RUBAN, M.D.
In Commercial Distribution

  • 03760087120721 ()

  • Length: 150 Millimeter
S3.3001u

  • Eyelid weight, implantable
An ophthalmic device that is implanted subcutaneously within the upper eyelid to "lidload" the eyelid to restore upper eyelid muscle (musculus orbicularis oculi) function. This device is used for the treatment of lagophthalmos, a condition that frequently results from facial paralysis caused by Bell's palsy, trauma, a stroke, or as an indirect consequence of the surgical removal of certain types of tumour in close proximity to the facial nerve. This device uses gravity to gently close the upper eyelid when blinking or when the eyelid muscle is relaxed, and is made of a heavy material [e.g., gold (Au), platinum (Pt)].
FCI S A S FCI 20 22
PTOSIS SLING SET LLOUQUET & GUERIN, M. D.
In Commercial Distribution

  • 33760087120715 ()
  • 03760087120714 ()

  • Length: 280 Millimeter
S3.1000u

  • Eyelid weight, implantable
A sterile device inserted into a punctal opening to prevent tear outflow in dry eye patients. This is a single-use device.
FCI S A S FCI 20 22
SNUG PLUG
In Commercial Distribution

  • 23760087120701 ()
  • 03760087120707 ()

  • Outer Diameter: 0.55 Millimeter
S2.4002u

  • Lacrimal punctum plug
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