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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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No Description
DIASORIN MOLECULAR LLC
MOL1001-P
In Commercial Distribution

  • 10816101025012 ()
MOL1001-P

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
DIASORIN MOLECULAR LLC
MOL1001
In Commercial Distribution

  • 10816101025005 ()
MOL1001

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
No Description
shenb Co., Ltd.
PlaDuo
In Commercial Distribution

  • 08800017100159 ()


  • Nitrogen plasma skin surface treatment system
No Description
PULMODYNE INC
313-9075
In Commercial Distribution

  • 10841470108165 ()
  • 00841470108168 ()


  • Ventilator breathing circuit, single-use
No Description
PULMODYNE INC
313-9074
In Commercial Distribution

  • 10841470108158 ()
  • 00841470108151 ()


  • Ventilator breathing circuit, single-use
No Description
PULMODYNE INC
313-9078
In Commercial Distribution

  • 00841470108144 ()
  • 10841470108141 ()


  • Ventilator breathing circuit, single-use
No Description
PULMODYNE INC
313-9076
In Commercial Distribution

  • 10841470108134 ()
  • 00841470108137 ()


  • Ventilator breathing circuit, single-use
No Description
PULMODYNE INC
313-9073
In Commercial Distribution

  • 00841470108120 ()
  • 10841470108127 ()


  • Ventilator breathing circuit, single-use
No Description
PULMODYNE INC
313-9072
In Commercial Distribution

  • 00841470108113 ()
  • 10841470108110 ()


  • Ventilator breathing circuit, single-use
No Description
PULMODYNE INC
313-9071
In Commercial Distribution

  • 00841470108106 ()
  • 10841470108103 ()


  • Ventilator breathing circuit, single-use
No Description
PULMODYNE INC
313-9070
In Commercial Distribution

  • 10841470108097 ()
  • 00841470108090 ()


  • Ventilator breathing circuit, single-use
No Description
KH Medical Co., Ltd.
KM005
In Commercial Distribution

  • 08800204300690 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
The RADI CHAMP260 is a stand-alone automated isothermal amplification and detection system for target nucleic acid sequences found in human specimens. The instrument is used in conjunction with KH Medical’s LOOP-Mediated Amplification in vitro diagnostic products. RADI CHAMP260 is designed to freely manipulate specific temperature and running time for amplification of samples by 7 inch touch screen. Amplification of target DNA occurs during the heat cycle and results in the formation of precipitate detected by the RADI CHAMP260 optics system. The precipitate generated by the presence of amplified target DNA leads to a turbid Sample/Control reaction solution which is then measured by absorbance. The RADI CHAMP260 uses the change in turbidity of each Sample/Control reaction solution to report assay results as INVALID, POSITIVE, or NEGATIVE on the 7 inch touch screen.
KH Medical Co., Ltd.
KM002
In Commercial Distribution

  • 08800204300096 ()


  • Thermal cycler nucleic acid amplification analyser IVD, laboratory
Gas Strut
MEDTEC, INC.
MTRHGS60
Not in Commercial Distribution

  • 00841439107201 ()

  • Length: 47 Centimeter
  • Width: 16 Centimeter
MTRHGS60

  • Thermoplastic-moulding water bath
Gas Strut
MEDTEC, INC.
MTRHGS01
In Commercial Distribution

  • 00841439107195 ()

  • Width: 16.9 Centimeter
  • Length: 46.8 Centimeter
MTRHGS01

  • Thermoplastic-moulding water bath
4 quart, 230V
MEDTEC, INC.
MT801.5DEX
Not in Commercial Distribution

  • 00841439111369 ()

  • Width: 13.05 Inch
  • Length: 14.87 Inch
MT801.5DEX

  • Melting pot unit
12 quart, 230V
MEDTEC, INC.
MT803DEX
Not in Commercial Distribution

  • 00841439111352 ()

  • Width: 17.95 Inch
  • Length: 17.868 Inch
MT803DEX

  • Melting pot unit
230V
MEDTEC, INC.
MTRH1500EX
In Commercial Distribution

  • 00841439111345 ()
MTRH1500EX

  • Thermoplastic-moulding water bath
120V
MEDTEC, INC.
MTRH1500
In Commercial Distribution

  • 00841439111338 ()
MTRH1500

  • Thermoplastic-moulding water bath
48 x 61cm
MEDTEC, INC.
MTCBPLLG
In Commercial Distribution

  • 00841439104101 ()
  • 10841439104108 ()

  • Length: 30 Inch
MTCBPLLG

  • Thermoplastic-moulding water bath
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