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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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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 device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a single-use device.
FCI S A S FCI 20 22
S6.3060
In Commercial Distribution

  • 13760087123712 ()
  • 03760087123715 ()


  • Surgical implant template, single-use
A sterile ophthalmic lens intended to be placed on the cornea of a patient to improve visualization of the fundus and retinal structures by surgical staff using an ophthalmic microscope during vitreoretinal surgery. Also known as a vitrectomy sutureless lens (VSL), it is made of various transparent materials [e.g., polymethylmethacrylate (PMMA), glass, quartz]. This is a single-use device.
FCI S A S FCI 20 22
DISPOSABLE PMMA AUTOSTABLE VITRECTOMY LENS, FLAT
In Commercial Distribution

  • 53760087123703 ()
  • 03760087123708 ()

  • Outer Diameter: 13 Millimeter
S5.8050U

  • Vitrectomy contact lens, single-use
A sterile ophthalmic lens intended to be placed on the cornea of a patient to improve visualization of the fundus and retinal structures by surgical staff using an ophthalmic microscope during vitreoretinal surgery. Also known as a vitrectomy sutureless lens (VSL), it is made of various transparent materials [e.g., polymethylmethacrylate (PMMA), glass, quartz]. This is a single-use device.
FCI S A S FCI 20 22
DISPOSABLE PMMA BICONCAVE LENS
In Commercial Distribution

  • 53760087123697 ()
  • 03760087123692 ()

  • Outer Diameter: 11.25 Millimeter
S5.8040U

  • Vitrectomy contact lens, single-use
A sterile ophthalmic lens intended to be placed on the cornea of a patient to improve visualization of the fundus and retinal structures by surgical staff using an ophthalmic microscope during vitreoretinal surgery. Also known as a vitrectomy sutureless lens (VSL), it is made of various transparent materials [e.g., polymethylmethacrylate (PMMA), glass, quartz]. This is a single-use device.
FCI S A S FCI 20 22
DISPOSABLE PMMA PRISMATIC 35° LENS
In Commercial Distribution

  • 53760087123680 ()
  • 03760087123685 ()

  • Outer Diameter: 11.25 Millimeter
S5.8030U

  • Vitrectomy contact lens, single-use
A sterile ophthalmic lens intended to be placed on the cornea of a patient to improve visualization of the fundus and retinal structures by surgical staff using an ophthalmic microscope during vitreoretinal surgery. Also known as a vitrectomy sutureless lens (VSL), it is made of various transparent materials [e.g., polymethylmethacrylate (PMMA), glass, quartz]. This is a single-use device.
FCI S A S FCI 20 22
DISPOSABLE PMMA VITRECTOMY LENS PLANOCONCAVE
In Commercial Distribution

  • 53760087123673 ()
  • 03760087123678 ()

  • Outer Diameter: 11.25 Millimeter
S5.8010U

  • Vitrectomy contact lens, single-use
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
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