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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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QCT PRO Asynchronous 3D Spine and CTXA-Hip System - B052QCTPROM4ASH0

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

Spetzler - OMT - M731100020

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

StaClear - B994SC250LL0

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

VLGR LEVEL 3 - B80002509000070

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

VLGR LEVEL 2 - B80002509000060

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

VLGR LEVEL 1 - B80002509000050

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

NORMAL HUMAN SERUM - B80002509000040

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

StaClear - B994SC250LS0

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 - D678F37050

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

URINE BROAD PANEL HIGH - B30001346000010

No Description
UTAK LABORATORIES, INC.
UBP H F V DU
In Commercial Distribution

  • B30001346000010 ()
  • B30001346000011 ()
  • B30001346000012 ()
  • B30001346000013 ()
  • B30001346000016 ()
  • B30001346000017 ()
  • B30001346000018 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

PURE ENRICHMENT - B311PETENSPAD0

ELECTRODE PADS
BEAR DOWN CONSULTING
PETENSPAD
In Commercial Distribution

  • B311PETENSPAD5 ()
  • B311PETENSPAD0 ()
  • B311PETENSPAD4 ()
  • B311PETENSPAD3 ()
  • B311PETENSPAD2 ()
  • B311PETENSPAD1 ()
  • B311PETENSPAD6 ()


  • Transcutaneous electrical stimulation electrode, single-use

PURE ENRICHMENT - B311PEPROPAD0

PACK OF ELECTRODES
BEAR DOWN CONSULTING
PEPROPAD
In Commercial Distribution

  • B311PEPROPAD0 ()
  • B311PEPROPAD4 ()
  • B311PEPROPAD3 ()
  • B311PEPROPAD2 ()
  • B311PEPROPAD1 ()
  • B311PEPROPAD5 ()
  • B311PEPROPAD6 ()


  • Transcutaneous electrical stimulation electrode, single-use

CONNECTOR, ADAPTER NEEDLE LUER - B066102357NS1

A non-sterile device designed to connect together two or more tubes typically with the intention of creating an extension. The connecting ends of this device will typically be serrated to provide a secure grip for the applied tubes. Clips or other forms of locking devices may be applied over the tubes to further secure the fitting. This device will not be appropriate for connecting tubes that are designed to carry (withstand) high pressures [e.g., high pressure gases]. This is a single-use device.
NOVOSCI CORP.
102357NS
In Commercial Distribution

  • B066102357NS1 ()
  • B066102357NS7 ()
  • B066102357NS6 ()
  • B066102357NS5 ()
  • B066102357NS4 ()
  • B066102357NS3 ()
  • B066102357NS2 ()
  • B066102357NS0 ()
102357NS

  • Non-ISO80369-standardized small-bore linear connector, single-use

BUSULFAN QC LEVEL 1 - B80010106500010

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

ACETAMINOPHEN PLUS 1 - B80010095200060

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

STOCK 4 - B80010095200050

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

STOCK 3 - B80010095200040

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

STOCK 2 - B80010095200030

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

STOCK 1 - B80010095200020

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

ACETAMINOPHEN PLUS HIGH - B80010095200010

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

DRUGS OF ABUSE CAL - B80010029000030

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

DRUGS OF ABUSE QC - B80010029000020

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

DRUGS OF ABUSE CAL - B80010029000010

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

AMPHETAMINE PLUS LEVEL 2 - B80006285000020

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

AMPHETAMINE PLUS LEVEL 1 - B80006285000010

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

BLANK WHOLE BLOOD - B80005200000010

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

OPIATES 500 NG/ML - B80004830000010

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 - B80004740000020

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 - B80004740000010

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% - B80004644000010

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

DAU QC HIGH V4 - B80004240000090

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

DAU QC MID V4 - B80004240000080

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

DAU QC LOW V4 - B80004240000070

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

DAU CALIBRATOR LEVEL 6 - B80004240000060

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

DAU CALIBRATOR LEVEL 5 - B80004240000050

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

DAU CALIBRATOR LEVEL 4 - B80004240000040

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

DAU CALIBRATOR LEVEL 3 - B80004240000030

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

DAU CALIBRATOR LEVEL 2 - B80004240000020

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

DAU CALIBRATOR LEVEL 1 - B80004240000010

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

CYSTATHIONINE PLUS LEVEL 2 - B80004000000020

No Description
UTAK LABORATORIES, INC.
CYST+ 2 LC
In Commercial Distribution

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


  • Multiple vitamin IVD, control
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