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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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NCL-L-HMB45 is intended for the qualitative identification by light microscopy of human HMB45 antigen in paraffin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
HMB45-L-CE
In Commercial Distribution

  • 05055331319326 ()
NCL-L-HMB45

  • Melanoma specific protein IVD, antibody
NCL-L-HMB45-U is intended for the qualitative identification by light microscopy of human HMB45 antigen in parrafin sections.
LEICA BIOSYSTEMS NEWCASTLE LTD
HMB45-L-U
In Commercial Distribution

  • 05055331333827 ()
NCL-L-HMB45-U

  • Melanoma specific protein IVD, antibody
The BFT II Analyzer is a semi-automated device intended for use to determine PT, APTT and Fibrinogen
Siemens Healthcare Diagnostics Products GmbH
10458677
In Commercial Distribution

  • 00842768024887 ()
OVKF032

  • Coagulation analyser IVD, laboratory, semi-automated
VistaTablet is a tablet which will be running the VistaPoint software user interface in a Web container
Vital Connect, Inc.
8102-01
In Commercial Distribution

  • 00850490007368 ()
8102-01

  • Electrocardiography telemetric monitoring system
VistaTablet is a tablet which will be running the VistaPoint software user interface in a Web container
Vital Connect, Inc.
8101-01
In Commercial Distribution

  • 00850490007207 ()
  • 00850490007276 ()
8101-01

  • Electrocardiography telemetric monitoring system
The Non-Contact Tonometer is intended to be used to measure the intraocular pressure of the human eye.
Huvitz Co., Ltd.
HNT-1
In Commercial Distribution

  • 08800019600428 ()
HNT-1

  • Ophthalmic tonometer, battery-operated
The Non-Contact Tonometer is intended to be used to measure the intraocular pressure of the human eye.
Huvitz Co., Ltd.
HNT-7000
In Commercial Distribution

  • 08800019600176 ()
HNT-7000

  • Ophthalmic tonometer, battery-operated
The Auto Ref/Keratometer is intended to be used to measure the refractive power of the eye
Huvitz Co., Ltd.
HRK-9000A
In Commercial Distribution

  • 08800019600169 ()
HRK-9000A

  • Ophthalmic refractometer, manual
The Auto Ref/Keratometer is intended to be used to measure the refractive power of the eye
Huvitz Co., Ltd.
HRK-8000A
In Commercial Distribution

  • 08800019600152 ()
HRK-8000A

  • Ophthalmic refractometer, manual
The Auto Ref/Keratometer is intended to be used to measure the refractive power of the eye
Huvitz Co., Ltd.
HRK-7000A
In Commercial Distribution

  • 08800019600145 ()
HRK-7000A

  • Ophthalmic refractometer, manual
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