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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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Irix A 42 x 30 x 17mm, 8 ° Trial Assy
Xtant Medical Holdings, Inc.
T080-423017-08TR
In Commercial Distribution

  • M697T08042301708TR0 ()
  • M697T08042301708TR1 ()

  • Angle: 8 degree
  • Length: 30 Millimeter
  • Height: 17 Millimeter
  • Width: 42 Millimeter


  • Spinal implant trial
Irix A 42 x 30 x 15mm, 8 ° Trial Assy
Xtant Medical Holdings, Inc.
T080-423015-08TR
In Commercial Distribution

  • M697T08042301508TR0 ()
  • M697T08042301508TR1 ()

  • Angle: 8 degree
  • Length: 30 Millimeter
  • Height: 15 Millimeter
  • Width: 42 Millimeter


  • Spinal implant trial
Irix A 42 x 30 x 13mm, 8 ° Trial Assy
Xtant Medical Holdings, Inc.
T080-423013-08TR
In Commercial Distribution

  • M697T08042301308TR0 ()
  • M697T08042301308TR1 ()

  • Angle: 8 degree
  • Width: 42 Millimeter
  • Length: 30 Millimeter
  • Height: 13 Millimeter


  • Spinal implant trial
Irix A 42 x 30 x 11mm, 8 ° Trial Assy
Xtant Medical Holdings, Inc.
T080-423011-08TR
In Commercial Distribution

  • M697T08042301108TR0 ()
  • M697T08042301108TR1 ()

  • Height: 11 Millimeter
  • Width: 42 Millimeter
  • Angle: 8 degree
  • Length: 30 Millimeter


  • Spinal implant trial
FluoroPerm® 30 (paflufocon C) rigid gas permeable contact lenses for daily wear are available as lathe cut or molded firm contact lenses with spherical, aspheric, bifocal or toric anterior and/or posterior; or, bitoric surfaces in clear and tinted versions. The posterior curve is selected so as to properly fit an individual eye and the anterior curve is selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea. The FluoroPerm® 30 rigid gas permeable contact lens material is a thermoset copolymer derived from fluorosilicone acrylate monomers. FluoroPerm® 30 rigid gas permeable tinted lenses offer a handling aid for locating the lens. These products may be plasma treated.
Paragon Vision Sciences, Inc.
Fluoroperm 30
In Commercial Distribution

  • B22206 ()


  • Rigid-gas-permeable corrective contact lens, daily-wear
More-Cell-System is intended for use as a tissue containment system during minimally invasive gynecologic laparoscopic surgeryto enable the isolation and containment of tissue considered benign, resected during multi-site laparoscopic surgery for powermorcellation and removal.
AMI Agency for Medical Innovations GmbH
MCS5551
In Commercial Distribution

  • MCS55511 ()
  • EAMIMCS55510 ()
MCS5551

  • Tissue extraction bag
Surgical motor system
Nouvag AG
3390
In Commercial Distribution

  • ENOU33900 ()


  • Line-powered surgical power tool system motor
Surgical motor system
Nouvag AG
3365
In Commercial Distribution

  • ENOU33650 ()


  • Line-powered surgical power tool system motor
Surgical motor system
Nouvag AG
3360
In Commercial Distribution

  • ENOU33600 ()


  • Surgical power tool system control unit, line-powered
Dental implant motor system
Nouvag AG
3330SAL
In Commercial Distribution

  • ENOU3330SAL0 ()


  • Remotely-driven dental drilling system motor
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