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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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Harms Colibri Fcps, .12mm W/Platforms
KATENA PRODUCTS, INC.
08-01221
In Commercial Distribution

  • 00857365004040 ()

  • Length: 0.12 Millimeter
08-01221

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
Precision Blade
GLAUKOS CORPORATION
AX1
In Commercial Distribution

  • 00853704002463 ()
AX1

  • Ophthalmic knife, single-use
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), and a stainless steel probe (protruding about 2.2 cm from the tip of the white outer shell and covered by a protective purge chamber). 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.
NEOMEDIX CORPORATION
550052-15
In Commercial Distribution

  • 00854028002184 ()
550052-15

  • Ophthalmic knife, single-use
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
Sauer Suturing Forceps, .6mm Teeth
KATENA PRODUCTS, INC.
08-01271
In Commercial Distribution

  • 00852979003854 ()

  • Length: 0.6 Millimeter
08-01271

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
Castroviejo Forceps, .12mm, Straight
KATENA PRODUCTS, INC.
08-01248
In Commercial Distribution

  • 00852979003847 ()

  • Length: 0.12 Millimeter
08-01248

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
Maskin Meibum Expressorâ„¢
KATENA PRODUCTS, INC.
08-01716
In Commercial Distribution

  • 00852979003809 ()
08-01716

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
Diamond Knife, 3-D Ang. Trap. 2.5-3.5mm
KATENA PRODUCTS, INC.
05-5086
In Commercial Distribution

  • 00852979003632 ()

  • Length: 2.5 Millimeter
  • Length: 3.5 Millimeter
05-5086

  • Ophthalmic knife, reusable
Diamond Knife, Angled, 3.0mm Blade
KATENA PRODUCTS, INC.
05-5050
In Commercial Distribution

  • 00852979003625 ()

  • Length: 3 Millimeter
05-5050

  • Ophthalmic knife, reusable
Castroviejo Forceps .12mm, Wide Handle
KATENA PRODUCTS, INC.
08-01254
In Commercial Distribution

  • 00852979003120 ()

  • Length: 0.12 Millimeter
08-01254

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
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