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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 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
PRE-LOADED PVP MINI PERFORATED PLUG J.A. BERNARD, M.D.
In Commercial Distribution

  • 23760087120572 ()
  • 03760087120578 ()

  • Outer Diameter: 0.7 Millimeter
S1.3522u

  • 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
PRE-LOADED PVP PERFORATED PLUG J.A. BERNARD, M.D.
In Commercial Distribution

  • 23760087120565 ()
  • 03760087120561 ()

  • Outer Diameter: 0.9 Millimeter
S1.3512u

  • Lacrimal punctum plug
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 MONO-CRAWFORD MEDIUM COLLARETTE B. FAYET, MD
In Commercial Distribution

  • 33760087120517 ()
  • 03760087120516 ()

  • Length: 320 Millimeter
  • Outer Diameter: 0.64 Millimeter
S1.1943u

  • 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
MONO-CRAWFORD WIDE COLLARETTE B. FAYET, MD
In Commercial Distribution

  • 33760087120500 ()
  • 03760087120509 ()

  • Outer Diameter: 0.64 Millimeter
S1.1913u

  • 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
PVP SELF-THREADING MONOKA FAYET, BERNARD, RITLENG
In Commercial Distribution

  • 33760087120487 ()
  • 03760087120486 ()

  • Outer Diameter: 0.64 Millimeter
S1.1820u

  • 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
SELF-THREADING MONOKA MEDIUM COLLARETTE FAYET, BERNARD, RITLENG
In Commercial Distribution

  • 33760087120470 ()
  • 03760087120479 ()

  • Outer Diameter: 0.64 Millimeter
S1.1810u

  • 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
SELF-THREADING MONOKA WIDE COLLARETTE FAYET, BERNARD, RITLENG
In Commercial Distribution

  • 33760087120463 ()
  • 03760087120462 ()

  • Outer Diameter: 0.64 Millimeter
S1.1800u

  • 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
MEDIUM COLLARETTE MONOKA ® BY FAYET & BERNARD ®
In Commercial Distribution

  • 33760087120456 ()
  • 03760087120455 ()

  • Length: 270 Millimeter
  • Outer Diameter: 0.64 Millimeter
S1.1710

  • 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
WIDE COLLARETTE MONOKA ® FAYET & BERNARD ®
In Commercial Distribution

  • 33760087120432 ()
  • 03760087120431 ()

  • Length: 270 Millimeter
  • Outer Diameter: 0.64 Millimeter
S1.1630

  • 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
PVP RITLENG BICANALICULUS INTUBATION
In Commercial Distribution

  • 03760087120387 ()

  • Outer Diameter: 0.64 Millimeter
S1.1490u

  • Lacrimal tube
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