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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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P.F.C. SIGMA FLUTED FEMORAL STEM 18mm x 125mm 7 DEGREE
DEPUY (IRELAND)
96-1703
In Commercial Distribution

  • 10603295239932 ()
961703

  • Knee femur stem prosthesis
P.F.C. SIGMA FLUTED FEMORAL STEM 16mm x 125mm 7 DEGREE
DEPUY (IRELAND)
96-1702
In Commercial Distribution

  • 10603295239925 ()
961702

  • Knee femur stem prosthesis
P.F.C. SIGMA FLUTED FEMORAL STEM 14mm x 125mm 7 DEGREE
DEPUY (IRELAND)
96-1701
In Commercial Distribution

  • 10603295239918 ()
961701

  • Knee femur stem prosthesis
P.F.C. SIGMA FLUTED FEMORAL STEM 12mm x 125mm 7 DEGREE
DEPUY (IRELAND)
96-1700
In Commercial Distribution

  • 10603295239901 ()
961700

  • Knee femur stem prosthesis
P.F.C. SIGMA FLUTED FEMORAL STEM 10mm x 125mm 7 DEGREE
DEPUY (IRELAND)
96-1699
In Commercial Distribution

  • 10603295239895 ()
961699

  • Knee femur stem prosthesis
The Carl Zeiss Meditec MEL 90 Excimer Laser System is designed for refractive surgery based on the ablation of corneal tissue achieved with a short pulse excimer laser having a wavelength of 193 nanometers. The laser head emits 4 to 7 nanosecond pulses (FWHM nominal pulse duration) with a repetition rate of 500 Hz. The MEL 90 Excimer Laser is a spot-scanning laser that utilizes a Gaussian beam with a 0.7 mm spot diameter. Indications for Use: The MEL 90 is indicated for use in primary Laser-Assisted in situ Keratomileusis (LASIK) treatments for the reduction or elimination of: • Myopia less in magnitude than -10.00 D sphere (in minus-cylinder notation), with and without cylinder up to -4.00 D, when MRSE is less in magnitude than -10.00 D; • Hyperopia up to +4.00 D sphere (in plus-cylinder notation), with and without cylinder up to +3.00 D, when MRSE is up to +5.00 D; and • Mixed astigmatism with cylinder from >1.00 D up to 4.00 D; in patients who are 18 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change in MRSE within +/- 0.50 D.
Carl Zeiss Meditec AG
1900-109
In Commercial Distribution

  • 04049471095074 ()

  • Weight: 295 Kilogram
  • x W x H: 1.63 m x 0.73 m x 1.48 m to 1.70 m


  • Ophthalmic excimer laser system
LAP-BAND® Access Port Needle 3.5 inch Pouch
ReShape Lifesciences Inc.
B-20301-10
In Commercial Distribution

  • 10850007764330 ()
  • 10811955020411 ()
  • 00850007764333 ()
B-20301-10

  • Subcutaneous infusion/injection port needle
LAP-BAND® Access Port Needle 2 inch Pouch
ReShape Lifesciences Inc.
B-20302-10
In Commercial Distribution

  • 10850007764323 ()
  • 10811955020428 ()
  • 00850007764326 ()
B-20302-10

  • Subcutaneous infusion/injection port needle
FRED 27
MICROVENTION INC.
FRED5526-PMA
In Commercial Distribution

  • 00842429106860 ()

  • 5.5 mm x 32 mm x 26mm
FRED5526

  • Bare-metal intracranial vascular stent
FRED-X 27
MICROVENTION INC.
FREDX5532-PMA
In Commercial Distribution

  • 00842429114490 ()

  • 5.5 mm x 32 mm x 26mm
FREDX5532

  • Bare-metal intracranial vascular stent
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