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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 intended use of the Noras OR Head holder is the fixation of the human skull just before, during and at the end of the intervention in the operating room.
Noras MRI products GmbH
01
In Commercial Distribution

  • 04251269205156 ()
113391

  • MRI system coil, radio-frequency
Pointe G6PD Reagent, 10 x 6ml, 1 x 120ml kit, For the quantitative, kinetic determination of glucose-6-phosphate dehydrogenase (G6PD) in blood at 340 nm. For in vitro diagnostic use only.
POINTE SCIENTIFIC, INC.
G7583-180
In Commercial Distribution

  • 00811727014139 ()
G7583-180

  • Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, kit, enzyme spectrophotometry
Bilirubin, Total Reagent Set for the quantitative determination of total bilirubin in serum on Hitachi analyzers. For in vitro diagnostic use only. Packaged at 6 x 90ml, 3 x 51ml
POINTE SCIENTIFIC, INC.
HB979-693
In Commercial Distribution

  • 00811727012586 ()
HB979-693

  • Total bilirubin IVD, kit, spectrophotometry
Bilirubin, Direct Reagent Set for the quantitative determination of direct bilirubin in serum on Hitachi analyzers. For in vitro diagnostic use only. Packaged at 12 x 19ml, 6 x 11ml
POINTE SCIENTIFIC, INC.
HB936-294
In Commercial Distribution

  • 00811727012579 ()
HB936-294

  • Conjugated (direct) bilirubin IVD, reagent
The ARK™ Pregabalin II Assay is an immunoassay intended for the qualitative and /or semi-quantitative determination of pregabalin in human urine at a cutoff concentration of 500 ng/mL.
ARK DIAGNOSTICS INC
5059-0001-01
In Commercial Distribution

  • 00812101031261 ()
5059-0001-01

  • Multiple anticonvulsant therapeutic drug monitoring IVD, reagent
The ARK™ Pregabalin II Assay is an immunoassay intended for the qualitative and/or semiquantitative determination of pregabalin in human urine at a cutoff concentration of 500 ng/mL.
ARK DIAGNOSTICS INC
5059-0001-00
In Commercial Distribution

  • 00812101030448 ()
5059-0001-00

  • Multiple anticonvulsant therapeutic drug monitoring IVD, reagent
Auto-retractable syringe. When the medication is fully discharged, the needle will be auto-retracted at the same time. Providing a safe use for healthworkers to minimize the risk of diseases cross-infection.
Shantou Wealy Medical Instrument Co., Ltd.
3ml 25Gx5/8"
In Commercial Distribution

  • 06971603580586 ()
  • 06971603580579 ()
  • 06971603580593 ()


  • Metered-delivery hypodermic syringe
Auto-retractable syringe. When the medication is fully discharged, the needle will be auto-retracted at the same time. Providing a safe use for healthworkers to minimize the risk of diseases cross-infection.
Shantou Wealy Medical Instrument Co., Ltd.
3ml 25Gx1"
In Commercial Distribution

  • 06971603580531 ()
  • 06971603580500 ()
  • 06971603580562 ()


  • Metered-delivery hypodermic syringe
Auto-retractable syringe. When the medication is fully discharged, the needle will be auto-retracted at the same time. Providing a safe use for healthworkers to minimize the risk of diseases cross-infection.
Shantou Wealy Medical Instrument Co., Ltd.
3ml 23Gx1"
In Commercial Distribution

  • 06971603580517 ()
  • 06971603580487 ()
  • 06971603580548 ()


  • Metered-delivery hypodermic syringe
Auto-retractable syringe. When the medication is fully discharge, the needle will be auto-retracted at the same time. Providing a safe use for healthworkers to minimize the risk of diseases cross-infection.
Shantou Wealy Medical Instrument Co., Ltd.
10ml 22Gx1 1/2"
In Commercial Distribution

  • 06971603580371 ()
  • 06971603580326 ()
  • 06971603580425 ()


  • Metered-delivery hypodermic syringe
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