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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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The ACTILINK mini is indicated for removing the hydrocarbon impurities on the surface of the endosseosous dental implants. According to the test results, it is verified that the plasma enhanced vacuuming flow can efficiently clean the hydrocarbon impurities on the implant surface. The ACTILINK mini can process: • Dental implant fixtures made of titanium or titanium alloy
Plasmapp Co.,Ltd.
ACTILINK mini
In Commercial Distribution

  • 08800066500245 ()


  • Plasma sterilizer
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
10” x 13” Absorbent Washcloth
Concordance Healthcare Solutions LLC
HCS0021-1010
In Commercial Distribution

  • 10810132040402 ()
  • 00810132040405 ()
  • 20810132040409 ()


  • Dry medical towel/wipe, single-use
Hospital Bed
HILL-ROM, INC.
P0819A
In Commercial Distribution

  • 00887761013834 ()


  • Air-fluidized bed
25 TOWELS, DISP, BLUE (FF) N/S
NOVO HEALTH SERVICES, LLC
0028
Not in Commercial Distribution

  • 00812564039996 ()
0028

  • Dry medical towel/wipe, single-use
Towel, White, 100-CT NS
NOVO HEALTH SERVICES, LLC
127563
Not in Commercial Distribution

  • 00812564039705 ()

  • Weight: 13.6 Pound
  • Width: 23 Inch
  • Height: 4 Inch
127563

  • Dry medical towel/wipe, single-use
Towel White FF, 25-Pack NS
NOVO HEALTH SERVICES, LLC
123650
Not in Commercial Distribution

  • 00812564039385 ()

  • Weight: 3.3 Pound
  • Width: 11 Inch
  • Height: 10 Inch
123650

  • Dry medical towel/wipe, single-use
Towel, Circ NS
NOVO HEALTH SERVICES, LLC
120176
Not in Commercial Distribution

  • 00812564035639 ()

  • Height: 1.5 Inch
  • Width: 5 Inch
  • Weight: 0.7 Pound
120176A

  • Dry medical towel/wipe, single-use
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