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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Convenience Kit consisting of - QCT Pro Asynchronous Calibration Module, CliniQCT - QCT Bone Mineral Density Analysis Software - CTXA Hip Bone Mineral Densitometer - CTXA Hip Extended Reference Database - Model 4 Calibration Phantom
MINDWAYS SOFTWARE, INC.
K894854K002113K030330K140342
In Commercial Distribution

  • B052QCTPROM4ASH0 ()
  • QCTPROM4ASHN0100 ()
  • QCTPROM4ASHN0075 ()
  • QCTPROM4ASHN0050 ()
  • QCTPROM4ASHN0025 ()
  • QCTPROM4ASHN0010 ()
  • QCTPROM4ASHN0005 ()
  • QCTPROM4ASHN0003 ()
  • QCTPROM4ASHN0002 ()
  • QCTPROM4ASHN0500 ()
  • QCTPROM4ASHN0200 ()
QCTPROM4ASH

  • CT system application software
Neuro Pattie; Sterile; X-Ray detectable; Tissue Compatible Rayon; For Single Use.
OMT, LLC
Neuro Patties
In Commercial Distribution

  • M731100020 ()
  • K900010 ()
  • M7311100149 ()
  • M7311100139 ()
  • M7311100129 ()
  • M7311100119 ()
  • M7311100109 ()
  • M7311100179 ()
  • M731110199 ()
  • M7311100199 ()
ALL

  • Cottonoid pad
The StaClear Model SC250LL Syringe is a single-use piston syringe consisting of a graduated barrel with luer lock connector, plunger, and plunger gasket. It is non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The StaClear Model SC250LL Syringe is suitable for ophthalmic use.
Staclear, Inc.
SC250LL
In Commercial Distribution

  • B994SC250LL0 ()
  • B994SC250LL1 ()
  • B994SC250LL5 ()
  • B994SC250LL2 ()
  • B994SC250LL3 ()
  • B994SC250LL4 ()
  • B994SC250LL6 ()
  • B994SC250LL7 ()

  • Total Volume: 0.25 Milliliter
SC250LL

  • General-purpose syringe/needle
No Description
UTAK LABORATORIES, INC.
VLGR 3 S F MAYO
In Commercial Distribution

  • B80002509000070 ()
  • B80002509000071 ()
  • B80002509000072 ()
  • B80002509000073 ()
  • B80002509000076 ()
  • B80002509000077 ()
  • B80002509000078 ()
  • B80002509000079 ()


  • Multiple-therapy therapeutic drug monitoring IVD, control
No Description
UTAK LABORATORIES, INC.
VLGR 2 S F MAYO
In Commercial Distribution

  • B80002509000060 ()
  • B80002509000061 ()
  • B80002509000062 ()
  • B80002509000063 ()
  • B80002509000066 ()
  • B80002509000067 ()
  • B80002509000068 ()
  • B80002509000069 ()


  • Multiple-therapy therapeutic drug monitoring IVD, control
No Description
UTAK LABORATORIES, INC.
VLGR 1 S F MAYO
In Commercial Distribution

  • B80002509000050 ()
  • B80002509000051 ()
  • B80002509000052 ()
  • B80002509000053 ()
  • B80002509000056 ()
  • B80002509000057 ()
  • B80002509000058 ()
  • B80002509000059 ()


  • Multiple-therapy therapeutic drug monitoring IVD, control
No Description
UTAK LABORATORIES, INC.
44600-S(MAYO)
In Commercial Distribution

  • B80002509000040 ()
  • B80002509000041 ()
  • B80002509000042 ()
  • B80002509000043 ()
  • B80002509000046 ()
  • B80002509000047 ()
  • B80002509000048 ()
  • B80002509000049 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
The StaClear Model SC250LS Syringe is a single-use piston syringe consisting of a graduated barrel with luer slip connector, plunger, and plunger gasket. It is non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The StaClear Model SC250LS Syringe is suitable for ophthalmic use.
Staclear, Inc.
SC250LS
In Commercial Distribution

  • B994SC250LS2 ()
  • B994SC250LS0 ()
  • B994SC250LS5 ()
  • B994SC250LS7 ()
  • B994SC250LS3 ()
  • B994SC250LS6 ()
  • B994SC250LS8 ()

  • Total Volume: 0.25 Milliliter


  • General-purpose syringe/needle
ScanX Classic for Intraoral & Extraoral Imaging is a device that scans photostimulable phosphor plates that have been exposed in the place of dental x-ray film and allows those images to be displayed on a CRT and stored for later recovery in a computer memory. It will be used by dentists and authorized dental auxiliary personnel for this purpose.
AIR TECHNIQUES, INC.
F3705
In Commercial Distribution

  • D678F37050 ()
  • D678F37001 ()
  • D678F3700U1 ()
  • D678F37051 ()
  • D678F3700C1 ()
  • D678F3750C1 ()
  • D678F37501 ()

  • Height: 24.5 Inch
  • Depth: 15.5 Inch
  • Width: 15.5 Inch
  • Weight: 51 Pound


  • Radiography digital imaging scanner
No Description
UTAK LABORATORIES, INC.
BUS QC 1 F SHP BHM
In Commercial Distribution

  • B80010106500010 ()
  • B80010106500011 ()
  • B80010106500012 ()
  • B80010106500013 ()
  • B80010106500016 ()
  • B80010106500017 ()
  • B80010106500018 ()


  • Busulfan therapeutic drug monitoring IVD, control
No Description
UTAK LABORATORIES, INC.
ACETA+ 1 S F BD
In Commercial Distribution

  • B80010095200061 ()
  • B80010095200060 ()
  • B80010095200062 ()
  • B80010095200063 ()
  • B80010095200066 ()
  • B80010095200067 ()
  • B80010095200068 ()


  • Multiple-therapy therapeutic drug monitoring IVD, control
No Description
UTAK LABORATORIES, INC.
STK 4 WB V2 BD 22
In Commercial Distribution

  • B80010095200051 ()
  • B80010095200050 ()
  • B80010095200052 ()
  • B80010095200053 ()
  • B80010095200056 ()
  • B80010095200057 ()
  • B80010095200058 ()


  • Multiple heavy metal IVD, control
No Description
UTAK LABORATORIES, INC.
STK 3 WB V2 BD 22
In Commercial Distribution

  • B80010095200041 ()
  • B80010095200040 ()
  • B80010095200042 ()
  • B80010095200043 ()
  • B80010095200046 ()
  • B80010095200047 ()
  • B80010095200048 ()


  • Multiple heavy metal IVD, control
No Description
UTAK LABORATORIES, INC.
STK 2 WB V2 BD 22
In Commercial Distribution

  • B80010095200030 ()
  • B80010095200031 ()
  • B80010095200032 ()
  • B80010095200033 ()
  • B80010095200036 ()
  • B80010095200037 ()
  • B80010095200038 ()


  • Multiple heavy metal IVD, control
No Description
UTAK LABORATORIES, INC.
STK 1 WB V2 BD 22
In Commercial Distribution

  • B80010095200020 ()
  • B80010095200021 ()
  • B80010095200022 ()
  • B80010095200023 ()
  • B80010095200026 ()
  • B80010095200027 ()
  • B80010095200028 ()


  • Multiple heavy metal IVD, control
No Description
UTAK LABORATORIES, INC.
ACETA+ HIGH V2 S F BD
In Commercial Distribution

  • B80010095200010 ()
  • B80010095200011 ()
  • B80010095200012 ()
  • B80010095200013 ()
  • B80010095200016 ()
  • B80010095200017 ()
  • B80010095200018 ()


  • Multiple-therapy therapeutic drug monitoring IVD, control
No Description
UTAK LABORATORIES, INC.
DA CAL M LB
In Commercial Distribution

  • B80010029000030 ()
  • B80010029000031 ()
  • B80010029000032 ()
  • B80010029000033 ()
  • B80010029000036 ()
  • B80010029000037 ()
  • B80010029000038 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
No Description
UTAK LABORATORIES, INC.
DA+ QC M LB
In Commercial Distribution

  • B80010029000020 ()
  • B80010029000021 ()
  • B80010029000022 ()
  • B80010029000023 ()
  • B80010029000026 ()
  • B80010029000027 ()
  • B80010029000028 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
No Description
UTAK LABORATORIES, INC.
DA+ CAL M LB
In Commercial Distribution

  • B80010029000011 ()
  • B80010029000010 ()
  • B80010029000012 ()
  • B80010029000013 ()
  • B80010029000016 ()
  • B80010029000017 ()
  • B80010029000018 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
No Description
UTAK LABORATORIES, INC.
AMPH+ 2 U V2 F WBH
In Commercial Distribution

  • B80006285000021 ()
  • B80006285000020 ()
  • B80006285000022 ()
  • B80006285000023 ()
  • B80006285000026 ()
  • B80006285000027 ()
  • B80006285000028 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
No Description
UTAK LABORATORIES, INC.
AMPH+ 1 U V2 F WBH
In Commercial Distribution

  • B80006285000010 ()
  • B80006285000011 ()
  • B80006285000012 ()
  • B80006285000013 ()
  • B80006285000016 ()
  • B80006285000017 ()
  • B80006285000018 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
No Description
UTAK LABORATORIES, INC.
44600-WB(F)50
In Commercial Distribution

  • B80005200000010 ()
  • B80005200000011 ()
  • B80005200000012 ()
  • B80005200000013 ()
  • B80005200000016 ()
  • B80005200000017 ()
  • B80005200000018 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
No Description
UTAK LABORATORIES, INC.
OPIA 500 U
In Commercial Distribution

  • B80004830000010 ()
  • B80004830000011 ()
  • B80004830000012 ()
  • B80004830000013 ()
  • B80004830000016 ()
  • B80004830000017 ()
  • B80004830000018 ()


  • Opiate/opiate metabolite IVD, control
BENZODIAZEPINES HIGH
UTAK LABORATORIES, INC.
BENZO H U F NDRH
In Commercial Distribution

  • B80004740000021 ()
  • B80004740000020 ()
  • B80004740000022 ()
  • B80004740000023 ()
  • B80004740000026 ()
  • B80004740000027 ()
  • B80004740000028 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
BENZODIAZEPINES LOW
UTAK LABORATORIES, INC.
BENZO L U F NDRH
In Commercial Distribution

  • B80004740000011 ()
  • B80004740000010 ()
  • B80004740000012 ()
  • B80004740000013 ()
  • B80004740000016 ()
  • B80004740000017 ()
  • B80004740000018 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
DRUGS OF ABUSE +50%
UTAK LABORATORIES, INC.
DAU SCR +50 SAFE
In Commercial Distribution

  • B80004644000011 ()
  • B80004644000010 ()
  • B80004644000012 ()
  • B80004644000013 ()
  • B80004644000016 ()
  • B80004644000017 ()
  • B80004644000018 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
No Description
UTAK LABORATORIES, INC.
DAU QC H V4 SEMCE
In Commercial Distribution

  • B80004240000090 ()
  • B80004240000091 ()
  • B80004240000092 ()
  • B80004240000093 ()
  • B80004240000096 ()
  • B80004240000097 ()
  • B80004240000098 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
No Description
UTAK LABORATORIES, INC.
DAU QC M V4 SEMCE
In Commercial Distribution

  • B80004240000080 ()
  • B80004240000081 ()
  • B80004240000082 ()
  • B80004240000083 ()
  • B80004240000086 ()
  • B80004240000087 ()
  • B80004240000088 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
No Description
UTAK LABORATORIES, INC.
DAU QC L V4 SEMCE
In Commercial Distribution

  • B80004240000070 ()
  • B80004240000071 ()
  • B80004240000072 ()
  • B80004240000073 ()
  • B80004240000076 ()
  • B80004240000077 ()
  • B80004240000078 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
No Description
UTAK LABORATORIES, INC.
DAU CAL 6 V4 F SEMCE
In Commercial Distribution

  • B80004240000060 ()
  • B80004240000061 ()
  • B80004240000062 ()
  • B80004240000063 ()
  • B80004240000066 ()
  • B80004240000067 ()
  • B80004240000068 ()


  • Multiple therapeutic drugs/drugs of abuse 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
No Description
UTAK LABORATORIES, INC.
DAU CAL 4 V4 F SEMCE
In Commercial Distribution

  • B80004240000040 ()
  • B80004240000041 ()
  • B80004240000042 ()
  • B80004240000043 ()
  • B80004240000046 ()
  • B80004240000047 ()
  • B80004240000048 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
No Description
UTAK LABORATORIES, INC.
DAU CAL 3 V4 F SEMCE
In Commercial Distribution

  • B80004240000030 ()
  • B80004240000031 ()
  • B80004240000032 ()
  • B80004240000033 ()
  • B80004240000036 ()
  • B80004240000037 ()
  • B80004240000038 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
No Description
UTAK LABORATORIES, INC.
DAU CAL 2 V4 F SEMCE
In Commercial Distribution

  • B80004240000020 ()
  • B80004240000021 ()
  • B80004240000022 ()
  • B80004240000023 ()
  • B80004240000026 ()
  • B80004240000027 ()
  • B80004240000028 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
No Description
UTAK LABORATORIES, INC.
DAU CAL 1 V4 F SEMCE
In Commercial Distribution

  • B80004240000010 ()
  • B80004240000011 ()
  • B80004240000012 ()
  • B80004240000013 ()
  • B80004240000016 ()
  • B80004240000017 ()
  • B80004240000018 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
No Description
UTAK LABORATORIES, INC.
CYST+ 2 LC
In Commercial Distribution

  • B80004000000020 ()
  • B80004000000021 ()
  • B80004000000022 ()
  • B80004000000023 ()
  • B80004000000026 ()
  • B80004000000027 ()
  • B80004000000028 ()


  • Multiple vitamin IVD, control
No Description
UTAK LABORATORIES, INC.
ALUM 18 NR DV
In Commercial Distribution

  • B80003935000010 ()
  • B80003935000011 ()
  • B80003935000012 ()
  • B80003935000013 ()
  • B80003935000016 ()
  • B80003935000017 ()
  • B80003935000018 ()


  • Aluminium IVD, control
No Description
UTAK LABORATORIES, INC.
ALP+ QC 2 V3 U F PT
In Commercial Distribution

  • B80003750000060 ()
  • B80003750000061 ()
  • B80003750000062 ()
  • B80003750000063 ()
  • B80003750000066 ()
  • B80003750000067 ()
  • B80003750000068 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
No Description
UTAK LABORATORIES, INC.
ALP+ QC 1 V3 U F PT
In Commercial Distribution

  • B80003750000051 ()
  • B80003750000050 ()
  • B80003750000052 ()
  • B80003750000053 ()
  • B80003750000056 ()
  • B80003750000057 ()
  • B80003750000058 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
No Description
UTAK LABORATORIES, INC.
ALP+ CAL 4 V3 U F PT
In Commercial Distribution

  • B80003750000040 ()
  • B80003750000041 ()
  • B80003750000042 ()
  • B80003750000043 ()
  • B80003750000046 ()
  • B80003750000047 ()
  • B80003750000048 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
No Description
UTAK LABORATORIES, INC.
ALP+ CAL 3 V3 U F PT
In Commercial Distribution

  • B80003750000030 ()
  • B80003750000031 ()
  • B80003750000032 ()
  • B80003750000033 ()
  • B80003750000036 ()
  • B80003750000037 ()
  • B80003750000038 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
No Description
UTAK LABORATORIES, INC.
ALP+ CAL 2 V3 U F PT
In Commercial Distribution

  • B80003750000021 ()
  • B80003750000020 ()
  • B80003750000022 ()
  • B80003750000023 ()
  • B80003750000026 ()
  • B80003750000027 ()
  • B80003750000028 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
No Description
UTAK LABORATORIES, INC.
ALP+ CAL 1 V3 U F PT
In Commercial Distribution

  • B80003750000010 ()
  • B80003750000011 ()
  • B80003750000012 ()
  • B80003750000013 ()
  • B80003750000016 ()
  • B80003750000017 ()
  • B80003750000018 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
BENZODIAZEPINES -25%
UTAK LABORATORIES, INC.
BENZO -25 PM
In Commercial Distribution

  • B80003716500101 ()
  • B80003716500100 ()
  • B80003716500102 ()
  • B80003716500103 ()
  • B80003716500106 ()
  • B80003716500107 ()
  • B80003716500108 ()

  • Total Volume: 10 Milliliter
BENZO -25 PM

  • Benzodiazepine group IVD, control
BENZODIAZEPINES +25%
UTAK LABORATORIES, INC.
BENZO +25 PM
In Commercial Distribution

  • B80003716500091 ()
  • B80003716500090 ()
  • B80003716500092 ()
  • B80003716500093 ()
  • B80003716500096 ()
  • B80003716500097 ()
  • B80003716500098 ()


  • Benzodiazepine group IVD, control
DRUGS OF ABUSE QC LEVEL 2
UTAK LABORATORIES, INC.
DA QC 2 OF PM
In Commercial Distribution

  • B80003716500081 ()
  • B80003716500080 ()
  • B80003716500082 ()
  • B80003716500083 ()
  • B80003716500086 ()
  • B80003716500087 ()
  • B80003716500088 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
DRUGS OF ABUSE QC LEVEL 1
UTAK LABORATORIES, INC.
DA QC 1 OF PM
In Commercial Distribution

  • B80003716500071 ()
  • B80003716500070 ()
  • B80003716500072 ()
  • B80003716500073 ()
  • B80003716500076 ()
  • B80003716500077 ()
  • B80003716500078 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
BUPRENORPHINE PLUS LEVEL 2
UTAK LABORATORIES, INC.
BUP+ 2 U PM
In Commercial Distribution

  • B80003716500061 ()
  • B80003716500060 ()
  • B80003716500062 ()
  • B80003716500063 ()
  • B80003716500066 ()
  • B80003716500067 ()
  • B80003716500068 ()


  • Opiate/opiate metabolite IVD, control
BUPRENORPHINE PLUS LEVEL 1
UTAK LABORATORIES, INC.
BUP+ 1 U PM
In Commercial Distribution

  • B80003716500051 ()
  • B80003716500050 ()
  • B80003716500052 ()
  • B80003716500053 ()
  • B80003716500056 ()
  • B80003716500057 ()
  • B80003716500058 ()


  • Opiate/opiate metabolite IVD, control
FENTANYL PLUS LEVEL 2
UTAK LABORATORIES, INC.
FENT+ 2 U PM
In Commercial Distribution

  • B80003716500041 ()
  • B80003716500040 ()
  • B80003716500042 ()
  • B80003716500043 ()
  • B80003716500046 ()
  • B80003716500047 ()
  • B80003716500048 ()


  • Opiate/opiate metabolite IVD, control
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