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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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STENT GRAFT ETLW1624C124E ENDUR II LIMB
MEDTRONIC, INC.
ETLW1624C124E
In Commercial Distribution

  • 00763000305611 ()

  • Stent Graft Length (Covered) 124 MM
  • Stent Graft Proximal Diameter 16 MM
  • Stent Graft Distal Diameter 24 MM


  • Abdominal aorta endovascular stent-graft
STENT GRAFT ETLW1624C146E ENDUR II LIMB
MEDTRONIC, INC.
ETLW1624C146E
In Commercial Distribution

  • 00763000519971 ()

  • Stent Graft Distal Diameter 24 MM
  • Stent Graft Proximal Diameter 16 MM
  • Stent Graft Length (Covered) 146 MM


  • Abdominal aorta endovascular stent-graft
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
Automated External Defibrillator
HEARTSINE TECHNOLOGIES LTD
SAM450P
In Commercial Distribution

  • 05060167129773 ()
450-STR-AS-GW

  • Non-rechargeable public semi-automated external defibrillator
Automated External Defibrillator
HEARTSINE TECHNOLOGIES LTD
SAM360P
In Commercial Distribution

  • 05060167129735 ()
360-STR-AS-GW

  • Non-rechargeable public automated external defibrillator
Automated External Defibrillator
HEARTSINE TECHNOLOGIES LTD
SAM350P
In Commercial Distribution

  • 05060167129711 ()
350-STR-AS-GW

  • Non-rechargeable public semi-automated external defibrillator
Automated External Defibrillator
HEARTSINE TECHNOLOGIES LTD
SAM 450P
In Commercial Distribution

  • 05060167128080 ()
450-STR-US-GW

  • Non-rechargeable public semi-automated external defibrillator
Automated External Defibrillator
HEARTSINE TECHNOLOGIES LTD
SAM 360P
In Commercial Distribution

  • 05060167128066 ()
360-STR-US-GW

  • Non-rechargeable public automated external defibrillator
Automated External Defibrillator
HEARTSINE TECHNOLOGIES LTD
SAM 350P
In Commercial Distribution

  • 05060167128042 ()
350-STR-US-GW

  • Non-rechargeable public semi-automated external defibrillator
Automated External Defibrillator
HEARTSINE TECHNOLOGIES LTD
SAM450P
In Commercial Distribution

  • 05060167120916 ()
450-STR-AS-10

  • Non-rechargeable public semi-automated external defibrillator
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