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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, implantable, single-lumen tube intended to provide tear drainage from the front surface of the eye, typically into the nasal cavity or a paranasal sinus, as a drainage treatment for lacrimal canalicular pathologies in functional or obstructive epiphora; it may also be intended to facilitate saline solution irrigation to a paranasal sinus (e.g., ethmoid sinus) to manage chronic rhinosinusitis. Also referred to as a lacrimal stent, the device may be implanted after surgery to dilate or create a surgical passage [e.g., dacryocystostomy/dacryocystorhinostomy (DCR)], and is made of glass or synthetic polymer material(s) [e.g., silicone].
FCI S A S FCI 20 22
PVP RITLENG BICANALICULUS INTUBATION
In Commercial Distribution

  • 03700773722037 ()

  • Outer Diameter: 0.64 Millimeter
S1.1491u

  • Lacrimal tube
A sterile, implantable, single-lumen tube intended to provide tear drainage from the front surface of the eye, typically into the nasal cavity or a paranasal sinus, as a drainage treatment for lacrimal canalicular pathologies in functional or obstructive epiphora; it may also be intended to facilitate saline solution irrigation to a paranasal sinus (e.g., ethmoid sinus) to manage chronic rhinosinusitis. Also referred to as a lacrimal stent, the device may be implanted after surgery to dilate or create a surgical passage [e.g., dacryocystostomy/dacryocystorhinostomy (DCR)], and is made of glass or synthetic polymer material(s) [e.g., silicone].
FCI S A S FCI 20 22
RITLENG BICANALICULUS INTUBATION
In Commercial Distribution

  • 03700773722020 ()

  • Length: 300 Millimeter
  • Outer Diameter: 0.64 Millimeter
S1.1451u

  • Lacrimal tube
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
An implantable short tube intended to provide a bypass route for tear drainage from the corner of the eye into the nasal cavity, or a paranasal sinus, as treatment for pathologies of the tear drainage system in association with functional or obstructive epiphora; it may also be intended to facilitate saline solution irrigation to a paranasal sinus (e.g., ethmoid sinus) to manage chronic rhinosinusitis. Also referred to as a lacrimal stent (e.g., Lester Jones type), it is implanted after surgery to dilate or maintain a surgically-created passage [e.g., dacryocystostomy/dacryocystorhinostomy (DCR)], and is made of glass or synthetic polymer materials (e.g., silicone).
FCI S A S FCI 20 22
S1.1495
In Commercial Distribution

  • 33760087127271 ()
  • 03760087127270 ()
  • 13760087127277 ()


  • Lacrimal tube
An implantable short tube intended to provide a bypass route for tear drainage from the corner of the eye into the nasal cavity, or a paranasal sinus, as treatment for pathologies of the tear drainage system in association with functional or obstructive epiphora; it may also be intended to facilitate saline solution irrigation to a paranasal sinus (e.g., ethmoid sinus) to manage chronic rhinosinusitis. Also referred to as a lacrimal stent (e.g., Lester Jones type), it is implanted after surgery to dilate or maintain a surgically-created passage [e.g., dacryocystostomy/dacryocystorhinostomy (DCR)], and is made of glass or synthetic polymer materials (e.g., silicone).
FCI S A S FCI 20 22
S1.1455
In Commercial Distribution

  • 33760087127264 ()
  • 03760087127263 ()
  • 13760087127260 ()


  • Lacrimal tube
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
PUNCTUM PLUGS - MINI PACK (MINI 0.7) J.A. BERNARD, M.D.
In Commercial Distribution

  • 03760087127188 ()

  • Outer Diameter: 0.55 Millimeter
S2.3724u

  • Lacrimal punctum plug
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
PUNCTUM PLUGS - VARIETYPACK (0.4-SL, 0.5-SL, 0.6, 0.7) J. A. BERNARD, M.D.
In Commercial Distribution

  • 03760087127171 ()

  • Outer Diameter: 0.43 Millimeter
S2.3624u

  • Lacrimal punctum plug
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
PUNCTUM PLUGS - MICRO PACK (MICRO, 0.6) J. A. BERNARD, M.D.
In Commercial Distribution

  • 03760087127164 ()

  • Outer Diameter: 0.45 Millimeter
S2.3524u

  • Lacrimal punctum plug
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
PUNCTUM PLUGS - SLIM PACK (SLIM PETITE, 0.5-SL) J. A. BERNARD, M.D.
In Commercial Distribution

  • 03760087127157 ()

  • Outer Diameter: 0.43 Millimeter
S2.3424u

  • Lacrimal punctum plug
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
PUNCTUM PLUGS - SLIM PACK (SLIM-MINI 0.4-SL) J. A. BERNARD, M.D.
In Commercial Distribution

  • 03760087127140 ()

  • Outer Diameter: 0.43 Millimeter
S2.3324U

  • Lacrimal punctum plug
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