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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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Transmitters and Receivers, Electrocardiograph, Telephone
UNIVERSAL MEDICAL, INC.
Heartrak Smart Rev 5
In Commercial Distribution

  • B147HTSM50 ()


  • Electrocardiography telemetric monitoring system
No Description
Great Lakes Dental Technologies, Ltd.
047-005
In Commercial Distribution

  • D7750470050 ()


  • Dental prosthesis restorative material, unfilled resin
No Description
Great Lakes Dental Technologies, Ltd.
047-002
In Commercial Distribution

  • D7750470020 ()


  • Dental prosthesis restorative material, unfilled resin
No Description
COSMEDENT, INC.
402658
In Commercial Distribution

  • D7734026581 ()


  • Dental abrasive disk, single-use
BUSULFAN CALIBRATOR LEVEL 5
UTAK LABORATORIES, INC.
BUS CAL 5 SJCR
In Commercial Distribution

  • B800BUSCAL5SJCR5 ()
  • B800BUSCAL5SJCR0 ()

  • Total Volume: 5 Milliliter
BUS CAL 5 SJCR

  • Multiple drugs of abuse IVD, control
Validity Control Level 5
UTAK LABORATORIES, INC.
17014
In Commercial Distribution

  • B800170140 ()
  • B800170145 ()

  • Total Volume: 25 Milliliter
17014

  • Multiple urine analyte IVD, control
No Description
UTAK LABORATORIES, INC.
DAU CAL 5 V4 F SEMCE
In Commercial Distribution

  • B80004240000050 ()
  • B80004240000051 ()
  • B80004240000052 ()
  • B80004240000053 ()
  • B80004240000056 ()
  • B80004240000057 ()
  • B80004240000058 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
MORPHINE 5 NG/M
UTAK LABORATORIES, INC.
pos-m245-1-2ml
In Commercial Distribution

  • B800POSM24512ML0 ()

  • Total Volume: 2 Milliliter
pos-m245-1-2ml

  • Multiple-therapy therapeutic drug monitoring IVD, control
ETG PLUS CALIBRATOR 5
UTAK LABORATORIES, INC.
ETG+ CAL 5 U F NPIL
In Commercial Distribution

  • B800ETGCAL5UFNPIL5 ()
  • B800ETGCAL5UFNPIL0 ()

  • Total Volume: 2 Milliliter
ETG+ CAL 5 U F NPIL

  • Multiple-type clinical chemistry analyte profile IVD, control
DAU CALIBRATOR LEVEL 5
UTAK LABORATORIES, INC.
DAU CAL 5 F ERSO
In Commercial Distribution

  • B800DAUCAL5FERSO5 ()
  • B800DAUCAL5FERSO0 ()

  • Total Volume: 4 Milliliter
DAU CAL 5 F ERSO

  • Multiple drugs of abuse IVD, control
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