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 STERLINK™ FPS-15s Plus sterilizer with STERLOAD™ cassette is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed, and dried reusable metal and nonmetal medical devices used in healthcare facilities. A pre-programmed sterilization lumen cycle operates at low pressure and low temperature and is thus suitable for processing medical devices sensitive to heat and moisture.
Plasmapp Co.,Ltd.
FPS-15s Plus
Not in Commercial Distribution

  • 08800066500054 ()


  • Plasma sterilizer
INSTITUTIONAL USE
AURORA MANUFACTURING, LLC
3000
In Commercial Distribution

  • B2844200002INST1 ()
4200002INST

  • Air-fluidized bed
HOME USE
AURORA MANUFACTURING, LLC
3000
In Commercial Distribution

  • B2844200002HU1 ()
4200002HU

  • Air-fluidized bed
CryoTip
FUJIFILM IRVINE SCIENTIFIC, INC.
40709-Pack
In Commercial Distribution

  • 00893727002118 ()
  • 10893727002115 ()
40709

  • Assisted reproduction cryotube
DRAPE, FENES STR 18"X26"
MCKESSON MEDICAL-SURGICAL INC.
25-517
In Commercial Distribution

  • 10612479182148 ()
  • 20612479182152 ()
  • 40612479182163 ()


  • Dry medical towel/wipe, single-use
DRAPE, LINED POLY STR WHT 18"X
MCKESSON MEDICAL-SURGICAL INC.
25-515
In Commercial Distribution

  • 10612479182117 ()
  • 20612479182121 ()
  • 40612479182132 ()


  • Dry medical towel/wipe, single-use
Air-Fluidized bed - see www.synergiecare.com AFCS PEARLS™ (SAT2) transport supports
Synergie Nederland B.V.
SAT2
In Commercial Distribution

  • 08720387388127 ()
2010312

  • Air-fluidized bed
Air-Fluidized bed - see www.synergiecare.com AFCS PEARLS™ (SAT2) & SANDS™ (SAT1) corner clamps
Synergie Nederland B.V.
SAT1 / SAT2
In Commercial Distribution

  • 08720387388110 ()
2010311

  • Air-fluidized bed
Air-Fluidized bed - see www.synergiecare.com AFCS PEARLS™ (SAT2) Air filter
Synergie Nederland B.V.
SAT2
In Commercial Distribution

  • 08720387388035 ()
2010601

  • Air-fluidized bed
Air-Fluidized bed - see www.synergiecare.com Extension hose to place the control unit seperate from the bed unit
Synergie Nederland B.V.
SAT2
In Commercial Distribution

  • 08720387388028 ()
2010310-US

  • Air-fluidized bed
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