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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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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 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
SPHERE INTRODUCER
In Commercial Distribution

  • 03760087126389 ()
S6.3050u

  • Orbital sphere implant introducer
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
SPHERE INTRODUCER
In Commercial Distribution

  • 03760087126297 ()
S6.3050u

  • Ophthalmic soft-tissue manipulation forceps, probe-like, reusable
A surgical instrument designed to accurately determine the depth of a recess (usually a drilled hole). It typically consists of a moveable (sliding) centrepiece (a prong), the tip of which is inserted into the recess; when the tip makes contact with the bottom a reading is visually taken from a scale marked on the side of the device. It is often used to measure the depth of holes being drilled in bone so that the surgeon can determine the length of the bone screw to be used. It is made of corrosive resistant materials [e.g., stainless steel, titanium (Ti)]. This is a reusable device intended to be sterilized prior to use.
FCI S A S FCI 20 22
PUNCTAL GAUGES FOR PLUG S2.3422U AND S2.3122U
In Commercial Distribution

  • 03760087126280 ()

  • Length: 119 Millimeter
S2.3067u

  • Surgical depth gauge, reusable
A surgical instrument designed to accurately determine the depth of a recess (usually a drilled hole). It typically consists of a moveable (sliding) centrepiece (a prong), the tip of which is inserted into the recess; when the tip makes contact with the bottom a reading is visually taken from a scale marked on the side of the device. It is often used to measure the depth of holes being drilled in bone so that the surgeon can determine the length of the bone screw to be used. It is made of corrosive resistant materials [e.g., stainless steel, titanium (Ti)]. This is a reusable device intended to be sterilized prior to use.
FCI S A S FCI 20 22
PUNCTAL GAUGES FOR PLUG S2.3652U AND S2.3672U
In Commercial Distribution

  • 03760087126273 ()

  • Length: 119 Millimeter
S2.3066u

  • Surgical depth gauge, reusable
A surgical instrument designed to accurately determine the depth of a recess (usually a drilled hole). It typically consists of a moveable (sliding) centrepiece (a prong), the tip of which is inserted into the recess; when the tip makes contact with the bottom a reading is visually taken from a scale marked on the side of the device. It is often used to measure the depth of holes being drilled in bone so that the surgeon can determine the length of the bone screw to be used. It is made of corrosive resistant materials [e.g., stainless steel, titanium (Ti)]. This is a reusable device intended to be sterilized prior to use.
FCI S A S FCI 20 22
PUNCTAL GAUGES FOR PLUG S2.3632U AND S2.3642U
In Commercial Distribution

  • 03760087126266 ()

  • Length: 119 Millimeter
S2.3065u

  • Surgical depth gauge, reusable
A hand-held manual surgical instrument intended to facilitate the manipulation of ocular structures or to remove foreign bodies in the eye. It is typically shaft-like with a small curve (blunt- or pointed-end) or bend distally, and a handle proximally. The device is commonly used to retract eye muscles or to stabilize and manoeuver tissue during posterior segment surgery. This is a reusable device.
FCI S A S FCI 20 22
RITLENG HOOK
In Commercial Distribution

  • 03760087126259 ()
S1.1480U

  • Ocular hook/spatula/manipulator, reusable
A hand-held manual instrument designed to grasp and manipulate intraocular tissues during ophthalmic surgery (e.g., anterior segment surgery, vitreo-retinal procedures, iridectomy, capsulorhexis). It has a probe-like design with a proximal handle (typically cylindrical), 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
ENDONASAL FORCEPS
In Commercial Distribution

  • 03760087126242 ()
S1.1470U

  • Ophthalmic soft-tissue manipulation forceps, probe-like, 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
RITLENG NASO-LACRIMAL PROBE
In Commercial Distribution

  • 03760087126235 ()
S1.1460u

  • Ophthalmic surgical probe, reusable
A hand-held manual surgical instrument intended to facilitate the manipulation of ocular structures or to remove foreign bodies in the eye. It is typically shaft-like with a small curve (blunt- or pointed-end) or bend distally, and a handle proximally. The device is commonly used to retract eye muscles or to stabilize and manoeuver tissue during posterior segment surgery. This is a reusable device.
FCI S A S FCI 20 22
CRAWFORD HOOK
In Commercial Distribution

  • 03760087126228 ()

  • Length: 78 Millimeter
S1.1275

  • Ocular hook/spatula/manipulator, reusable
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