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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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Endo Direct LLC
EDSH480ML3
In Commercial Distribution

  • 10810138822668 ()


  • Root canal cleaning solution
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
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 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
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