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
SIGNATURE ORTHOPAEDICS PTY LTD
122-22-1628
In Commercial Distribution

  • 09348215127596 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
IMMUNOSUPPRESSANTS QC 3
UTAK LABORATORIES, INC.
025090-0003
In Commercial Distribution

  • B80002509000033 ()
  • B80002509000030 ()

  • Total Volume: 10 Milliliter
IMMU 3 MAYO V2

  • Multiple immunosuppressant therapeutic drug monitoring IVD, control
IMMUNOSUPPRESSANTS QC 2
UTAK LABORATORIES, INC.
025090-0002
In Commercial Distribution

  • B80002509000020 ()
  • B80002509000023 ()

  • Total Volume: 10 Milliliter
IMMU 2 MAYO V2

  • Multiple immunosuppressant therapeutic drug monitoring IVD, control
IMMUNOSUPPRESSANTS QC 1
UTAK LABORATORIES, INC.
025090-0001
In Commercial Distribution

  • B80002509000013 ()
  • B80002509000010 ()

  • Total Volume: 10 Milliliter
IMMU 1 MAYO V2

  • Multiple immunosuppressant therapeutic drug monitoring IVD, control
DNA quantitation and normalization of DNA concentration
Magbio Genomics, Inc.
MagQuant™ Plus DNA V2
In Commercial Distribution

  • 00850045030445 ()
MQP-50096

  • Nucleic acid library construction kit IVD
DNA quantitation and normalization of DNA concentration
Magbio Genomics, Inc.
MagQuant™ Plus DNA V2
In Commercial Distribution

  • 00850045030469 ()
MQP-51920

  • Nucleic acid library construction kit IVD
DNA quantitation and normalization of DNA concentration
Magbio Genomics, Inc.
MagQuant™ Plus DNA V2
In Commercial Distribution

  • 00850045030452 ()
MQP-50384

  • Nucleic acid library construction kit IVD
No Description
INTOUCH TECHNOLOGIES, INC.
Lite Remote Presence System V2
In Commercial Distribution

  • 00868772000150 ()


  • Diagnostic imaging telemedicine system
A mains electricity (AC-powered) device specifically designed to be used when placed in a bed or chair. It may be fixed into appropriate beds or chairs providing other functions. It will provide a massaging therapeutic effect to the person occupying the bed or chair typically to ease aches and pains in the body. It may be used in an institution, but is typically designed for home use.
Human Touch, LLC
HT GRAVIS BLACK BASE V2
In Commercial Distribution

  • 00045915829506 ()
100-GRAVIS-003

  • Bed/chair electric massager
A mains electricity (AC-powered) device specifically designed to be used when placed in a bed or chair. It may be fixed into appropriate beds or chairs providing other functions. It will provide a massaging therapeutic effect to the person occupying the bed or chair typically to ease aches and pains in the body. It may be used in an institution, but is typically designed for home use.
Human Touch, LLC
HT GRAVIS MAHOGANY BASE V2
In Commercial Distribution

  • 00045915829674 ()
100-GRAVIS-005

  • Bed/chair electric massager
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