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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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FILE HOLDER B FOR IROOT 100
META SYSTEMS CO., LTD.
iRB-009
Not in Commercial Distribution

  • 08809455600658 ()


  • Endodontic apex locator
FILE HOLDER A FOR IROOT 100
META SYSTEMS CO., LTD.
iRB-008
Not in Commercial Distribution

  • 08809455600641 ()


  • Endodontic apex locator
i-ROOT 100
META SYSTEMS CO., LTD.
iRB-003
Not in Commercial Distribution

  • 08809455600634 ()


  • Endodontic apex locator
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
S1.1550
In Commercial Distribution

  • 13700773723277 ()
  • 03700773723270 ()


  • 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
S1.1545
In Commercial Distribution

  • 13700773723260 ()
  • 03700773723263 ()


  • 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
S1.1522
In Commercial Distribution

  • 13700773723253 ()
  • 03700773723256 ()


  • 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
S1.1515
In Commercial Distribution

  • 13700773723246 ()
  • 03700773723249 ()


  • Lacrimal intubation set
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

  • 03700773722181 ()

  • Length: 320 Millimeter
  • Outer Diameter: 0.64 Millimeter
S1.1951u

  • 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

  • 03700773722150 ()

  • Length: 320 Millimeter
  • Outer Diameter: 0.64 Millimeter
S1.1941u

  • 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

  • 03700773722143 ()

  • Length: 320 Millimeter
  • Outer Diameter: 0.64 Millimeter
S1.1911u

  • Lacrimal tube
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