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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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The Handpiece is a sterile single use ophthalmic knife. It consists of a pencil-like instrument with a graspable white ABS plastic outer shell (~1.5 cm diameter and ~13 cm length), a stainless steel probe (protruding about 2.2 cm from the tip of the white outer shell and covered by a protective purge chamber), irrigation and aspiration tubing extruded from DEHP-free PVC (~15 cm length) terminated with polycarbonate luer connectors. The diameter of the probe insertable into the eye is ~1.1 mm. The tip of the probe features a pointed footplate tip and dual sharpened edges fabricated of stainless steel. The Handpiece is intended to be used in ophthalmic surgery to manually cut Trabecular Meshwork (TM) in adult and infantile patients. The Handpiece can be connected to a suitable ophthalmic Irrigation/Aspiration (I/A) system to provide irrigation and aspiration of balanced salt solution (BSS) while the procedure is being performed.
NEOMEDIX CORPORATION
550052-11
In Commercial Distribution

  • 00854028002177 ()


  • Ophthalmic knife, single-use
TEMPORARY FIXATION INSTRUMENT, RIB, 2.3 MM SCREW
KLS-Martin L.P.
24-015-67-71
In Commercial Distribution

  • 00888118106063 ()

  • 69 MM


  • Orthopaedic bone-fragment manipulator, single-use
ProTekt Slit Knife, 2.4mm, Single Bevel, Angled, Multi-Use
Diamatrix
PG 44515MU
In Commercial Distribution

  • 00813059014276 ()
  • 00813059014290 ()


  • Ophthalmic knife, reusable
ProTekt MicroTrapKnife, 1.9/2.4mm , Angled, Multi-Use
Diamatrix
PG 44870MU
In Commercial Distribution

  • 00813059011701 ()
  • 00813059012111 ()


  • Ophthalmic knife, reusable
ProTekt MicroTrap Knife, 1.6/1.8mm , Angled, Multi-Use
Diamatrix
PG 44890MU
In Commercial Distribution

  • 00813059011695 ()
  • 00813059012098 ()


  • Ophthalmic knife, reusable
ProTekt Williamson Trapezoid Knife, 2.7/3.2mm, Angled
Diamatrix
PG 44820SS
In Commercial Distribution

  • 00813059011640 ()
  • 00813059012067 ()


  • Ophthalmic knife, single-use
ProTekt Clear Corneal Knife, 2.75mm, Angled, Multi-Use
Diamatrix
PG 44570MU
In Commercial Distribution

  • 00813059011633 ()
  • 00813059012043 ()


  • Ophthalmic knife, reusable
ProTekt Clear Corneal Knife, 2.85mm, Angled, Multi-Use
Diamatrix
PG 44610MU
In Commercial Distribution

  • 00813059011626 ()
  • 00813059012036 ()


  • Ophthalmic knife, reusable
ProTekt Clear Corneal Knife, 3.0mm, Angled, Multi-Use
Diamatrix
PG 44590MU
In Commercial Distribution

  • 00813059011619 ()
  • 00813059012029 ()


  • Ophthalmic knife, reusable
ProTekt Clear Corneal Knife, 2.85mm, Angled
Diamatrix
PG 44610SS
In Commercial Distribution

  • 00813059011572 ()
  • 00813059011985 ()


  • Ophthalmic knife, single-use
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