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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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AUTOSTABLE BICANALICULUS INTUBATION SET II (35 MM) WITH DILATOR
FCI S A S FCI 20 22
S1.1392
In Commercial Distribution

  • 13760087120346 ()
  • 03760087120349 ()


  • Lacrimal tube
AUTOSTABLE BICANALICULUS INTUBATION SET II (30 MM) WITH DILATOR
FCI S A S FCI 20 22
S1.1391
In Commercial Distribution

  • 13760087120339 ()
  • 03760087120332 ()


  • Lacrimal tube
AUTOSTABLE BICANALICULUS INTUBATION SET II (25 MM) WITH DILATOR
FCI S A S FCI 20 22
S1.1390
In Commercial Distribution

  • 13760087120322 ()
  • 03760087120325 ()


  • 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
CRAWFORD BICANALICULUS INTUBATION
In Commercial Distribution

  • 33760087120234 ()
  • 03760087120233 ()

  • Length: 310 Millimeter
  • Outer Diameter: 0.64 Millimeter
S1.1270u

  • 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
INFANT BIKA BICANALICULUS INTUBATION J.A. BERNARD, M.D.
In Commercial Distribution

  • 33760087120173 ()
  • 03760087120172 ()

  • Length: 55 Millimeter
  • Outer Diameter: 0.64 Millimeter
S1.1100

  • Lacrimal tube
BIKA BICANALICULAR INTUBATION SET J.A. BERNARD, M.D.
FCI S A S FCI 20 22
S1.1000
In Commercial Distribution

  • 33760087120104 ()
  • 03760087120103 ()


  • Lacrimal tube
A sterile device inserted into a lacrimal punctum opening to prevent tear outflow in dry eye patients. This is a single-use device.
FCI S A S FCI 20 22
READY-SET PUNCTUM PLUG (MINI, US 0.7)
In Commercial Distribution

  • 23760087120060 ()
  • 03760087120066 ()

  • Outer Diameter: 0.55 Millimeter
S2.3672u

  • Lacrimal punctum plug
No Description
CG MedTech Co.,Ltd.
FSA5550
In Commercial Distribution

  • 08800015994781 ()


  • Spinal bone screw, non-bioabsorbable
No Description
CG MedTech Co.,Ltd.
FSA5545
In Commercial Distribution

  • 08800015994774 ()


  • Spinal bone screw, non-bioabsorbable
No Description
CG MedTech Co.,Ltd.
FSA5540
In Commercial Distribution

  • 08800015994767 ()


  • Spinal bone screw, non-bioabsorbable
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