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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
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
A collection of devices intended to be used to maintain patency of the nasolacrimal system typically for treating/preventing pathologies of the tear drainage system (e.g., post-chemotherapy stenosis) or after dacryocystorhinostomy (DCR). It consists of a long and flexible bicanalicular or monocanalicular tube (e.g., Crawford type) inserted through the lacrimal puncta into the canaliculi, lacrimal sac, and/or nasolacrimal duct; devices to assist the intubation procedure are typically provided preassembled to the tube (e.g., cannula, probes, bougies, introducer, stylet). The tube is typically left in place long-term before removal. This is a single-use device.
FCI S A S FCI 20 22
S1.1540
In Commercial Distribution

  • 13760087123965 ()
  • 03760087123968 ()


  • Lacrimal intubation set
A collection of devices intended to be used to maintain patency of the nasolacrimal system typically for treating/preventing pathologies of the tear drainage system (e.g., post-chemotherapy stenosis) or after dacryocystorhinostomy (DCR). It consists of a long and flexible bicanalicular or monocanalicular tube (e.g., Crawford type) inserted through the lacrimal puncta into the canaliculi, lacrimal sac, and/or nasolacrimal duct; devices to assist the intubation procedure are typically provided preassembled to the tube (e.g., cannula, probes, bougies, introducer, stylet). The tube is typically left in place long-term before removal. This is a single-use device.
FCI S A S FCI 20 22
S1.1535
In Commercial Distribution

  • 13760087123958 ()
  • 03760087123951 ()


  • Lacrimal intubation set
A collection of devices intended to be used to maintain patency of the nasolacrimal system typically for treating/preventing pathologies of the tear drainage system (e.g., post-chemotherapy stenosis) or after dacryocystorhinostomy (DCR). It consists of a long and flexible bicanalicular or monocanalicular tube (e.g., Crawford type) inserted through the lacrimal puncta into the canaliculi, lacrimal sac, and/or nasolacrimal duct; devices to assist the intubation procedure are typically provided preassembled to the tube (e.g., cannula, probes, bougies, introducer, stylet). The tube is typically left in place long-term before removal. This is a single-use device.
FCI S A S FCI 20 22
S1.1530
In Commercial Distribution

  • 13760087123941 ()
  • 03760087123944 ()


  • Lacrimal intubation set
FCI NUNCHAKU 105
FCI S A S FCI 20 22
S1.1371
In Commercial Distribution

  • 13760087123743 ()
  • 03760087123746 ()


  • Lacrimal tube
FCI NUNCHAKU 90
FCI S A S FCI 20 22
S1.1361
In Commercial Distribution

  • 13760087123736 ()
  • 03760087123739 ()


  • 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
MASTERKA ® 40 (DESIGNER B. FAYET, M.D.)
In Commercial Distribution

  • 03760087123661 ()

  • Length: 40 Millimeter
  • Outer Diameter: 0.90 Millimeter
S1.1610

  • 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
MASTERKA ® 35 (DESIGNER B. FAYET, M.D.)
In Commercial Distribution

  • 03760087123654 ()

  • Length: 35 Millimeter
  • Outer Diameter: 0.90 Millimeter
S1.1609

  • 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
MASTERKA ® 30 (DESIGNER B. FAYET, M.D.)
In Commercial Distribution

  • 03760087123647 ()

  • Length: 30 Millimeter
  • Outer Diameter: 0.90 Millimeter
S1.1608

  • 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
SNUG PLUG
In Commercial Distribution

  • 23760087120701 ()
  • 03760087120707 ()

  • Outer Diameter: 0.55 Millimeter
S2.4002u

  • Lacrimal punctum plug
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