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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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3D Fusion™ Firm Matrix Band Special Kit: 80 Count (20) FXH100, (20) FXH175, (20) FXH200, (20) FXH300
GARRISON DENTAL SOLUTIONS, L.L.C.
FXHB03
In Commercial Distribution

  • 00810038095349 ()
FXHB03

  • Dental matrix band, single-use
A hand-held manual ophthalmic instrument designed to hold and insert an orbital sphere implant into the orbital cavity (eye socket). It typically has a body made of high-grade stainless steel with a piston used to forward the implant, which is held and positioned by the size-adjustable head of the device. This is a reusable device.
FCI S A S FCI 20 22
S6.3050
In Commercial Distribution

  • 13760087126386 ()


  • Orbital sphere implant introducer
A hand-held manual ophthalmic surgical instrument with small blades designed to grasp and manipulate ophthalmic implants (excluding sutures) during implantation/explantation; it is not intended for use on tissues. Its design may be tweezers-like, or it may be probe-like with a proximal handle, a thin cannula-like shaft, and small grasping blades that protrude from the distal end of the shaft. This is a reusable device intended to be sterilized prior to use.
FCI S A S FCI 20 22
S5.3100
In Commercial Distribution

  • 13760087126294 ()


  • Ophthalmic implant handling forceps, reusable
A slender hand-held manual instrument with a hook at its distal end designed to be inserted through the nose to extract a tube, cannula, or probe previously inserted into the lacrimal drainage system (the lacrimal duct), by pulling it out through the nose. This is a reusable device.
FCI S A S FCI 20 22
S1.1480
In Commercial Distribution

  • 13760087126256 ()


  • Transnasal lacrimal tube extractor
A hand-held manual ophthalmic surgical instrument with small blades designed to grasp and manipulate ophthalmic implants (excluding sutures) during implantation/explantation; it is not intended for use on tissues. Its design may be tweezers-like, or it may be probe-like with a proximal handle, a thin cannula-like shaft, and small grasping blades that protrude from the distal end of the shaft. This is a reusable device intended to be sterilized prior to use.
FCI S A S FCI 20 22
S1.1470
In Commercial Distribution

  • 13760087126249 ()


  • Ophthalmic implant handling forceps, reusable
A hand-held, manual, slender rod-like ophthalmic surgical instrument made of flexible metal, with a blunt bulbous tip, used for exploring the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. This is a reusable device.
FCI S A S FCI 20 22
S1.1460
In Commercial Distribution

  • 13760087126232 ()


  • Ophthalmic surgical probe, reusable
No Description
FCI S A S FCI 20 22
S1.1275
In Commercial Distribution

  • 13760087126225 ()


  • Transnasal lacrimal tube extractor
No Description
FCI S A S FCI 20 22
A8.4050
In Commercial Distribution

  • 13760087126072 ()


  • Ophthalmic surgical probe, reusable
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
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