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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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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, 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 WIDE COLLARETTE B. FAYET, MD
In Commercial Distribution

  • 33760087120623 ()
  • 03760087120622 ()

  • Length: 320 Millimeter
  • Outer Diameter: 0.64 Millimeter
S1.1953u

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

  • 33760087120494 ()
  • 03760087120493 ()

  • Outer Diameter: 0.64 Millimeter
S1.1903u

  • 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
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