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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TCA 200 NG/ML
UTAK LABORATORIES, INC.
TCA 200 V2 S LHS
In Commercial Distribution

  • B800TCA200V2SLHS5 ()
  • B800TCA200V2SLHS0 ()

  • Total Volume: 5 Milliliter
TCA 200 V2 S LHS

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE LEVEL 3
UTAK LABORATORIES, INC.
SMX-DAU 3 V2 F PG
In Commercial Distribution

  • B800SMXDAU3V2FPG5 ()
  • B800SMXDAU3V2FPG0 ()

  • Total Volume: 2 Milliliter
SMX-DAU 3 V2 F PG

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE LEVEL 2
UTAK LABORATORIES, INC.
SMX-DAU 2 V2 F PG
In Commercial Distribution

  • B800SMXDAU2V2FPG5 ()
  • B800SMXDAU2V2FPG0 ()

  • Total Volume: 2 Milliliter
SMX-DAU 2 V2 F PG

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE LEVEL 1
UTAK LABORATORIES, INC.
SMX-DAU 1 V2 F PG
In Commercial Distribution

  • B800SMXDAU1V2FPG5 ()
  • B800SMXDAU1V2FPG0 ()

  • Total Volume: 2 Milliliter
SMX-DAU 1 V2 F PG

  • Multiple-type clinical chemistry analyte profile IVD, control
PENTOBARBITAL LEVEL 2
UTAK LABORATORIES, INC.
PENTO 2 V2 S BH
In Commercial Distribution

  • B800PENTO2V2SBH5 ()
  • B800PENTO2V2SBH0 ()

  • Total Volume: 5 Milliliter
PENTO 2 V2 S BH

  • Multiple-type clinical chemistry analyte profile IVD, control
OPIATES URINE QC
UTAK LABORATORIES, INC.
OPIA 1 V2 U WHM
In Commercial Distribution

  • B800OPIA1V2UWHM5 ()
  • B800OPIA1V2UWHM0 ()

  • Total Volume: 5 Milliliter
OPIA 1 V2 U WHM

  • Multiple-type clinical chemistry analyte profile IVD, control
NIDA CUTOFF
UTAK LABORATORIES, INC.
NIDA CUT V2 F CRL
In Commercial Distribution

  • B800NIDACUTV2FCRL5 ()
  • B800NIDACUTV2FCRL0 ()

  • Total Volume: 120 Milliliter
NIDA CUT V2 F CRL

  • Multiple drugs of abuse IVD, control
FENTANYL PLUS LEVEL 4
UTAK LABORATORIES, INC.
FENT+ 4 V2 U NJSP
In Commercial Distribution

  • B800FENT4V2UNJSP5 ()
  • B800FENT4V2UNJSP0 ()

  • Total Volume: 5 Microliter
FENT+ 4 V2 U NJSP

  • Multiple-type clinical chemistry analyte profile IVD, control
ETHANOL 50 MG/DL
UTAK LABORATORIES, INC.
ETH 50 V2 U UMMC
In Commercial Distribution

  • B800ETH50V2UUMMC5 ()
  • B800ETH50V2UUMMC0 ()

  • Total Volume: 5 Milliliter
ETH 50 V2 U UMMC

  • Multiple-type clinical chemistry analyte profile IVD, control
AXIS VOL QC #4
UTAK LABORATORIES, INC.
ETH 350 V2 W AIT
In Commercial Distribution

  • B800ETH350V2WAIT5 ()
  • B800ETH350V2WAIT0 ()

  • Total Volume: 5 Milliliter
ETH 350 V2 W AIT

  • Multiple-type clinical chemistry analyte profile IVD, control
ETHANOL 20 MG/DL
UTAK LABORATORIES, INC.
ETH 20 V2 U UMMC
In Commercial Distribution

  • B800ETH20V2UUMMC5 ()
  • B800ETH20V2UUMMC0 ()

  • Total Volume: 5 Milliliter
ETH 20 V2 U UMMC

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE
UTAK LABORATORIES, INC.
DA WB 2PT V2 SDHL
In Commercial Distribution

  • B800DAWB2PTV2SDHL5 ()
  • B800DAWB2PTV2SDHL0 ()

  • Total Volume: 2 Milliliter
DA WB 2PT V2 SDHL

  • Multiple-type clinical chemistry analyte profile IVD, control
PENTOBARBITAL LEVEL 1
UTAK LABORATORIES, INC.
PENTO 1 V2 S BH
In Commercial Distribution

  • B800PENTO1V2SBH5 ()
  • B800PENTO1V2SBH0 ()

  • Total Volume: 5 Milliliter
PENTO 1 V2 S BH

  • Multiple-type clinical chemistry analyte profile IVD, control
NIDA LOW
UTAK LABORATORIES, INC.
NIDA LOW V2 F CRL
In Commercial Distribution

  • B800NIDALOWV2FCRL5 ()
  • B800NIDALOWV2FCRL0 ()

  • Total Volume: 120 Milliliter
NIDA LOW V2 F CRL

  • Multiple drugs of abuse IVD, control
MD LABS 43 DRUGS LOW
UTAK LABORATORIES, INC.
MD LABS 43 V2 LOW
In Commercial Distribution

  • B800MDLABS43V2LOW5 ()
  • B800MDLABS43V2LOW0 ()

  • Total Volume: 1 Milliliter
MD LABS 43 V2 LOW

  • Multiple-type clinical chemistry analyte profile IVD, control
MD LABS 43 DRUGS HIGH
UTAK LABORATORIES, INC.
MD LABS 43 V2 HIGH
In Commercial Distribution

  • B800MDLABS43V2HIGH0 ()

  • Total Volume: 1 Milliliter
MD LABS 43 V2 HIGH

  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
IMPLANET
Madison BL Threaded Rod V2
In Commercial Distribution

  • 03607505404547 ()
540454

  • Orthopaedic surgical procedure kit, non-medicated, reusable
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
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 BEECH BASE V2
In Commercial Distribution

  • 00045915829667 ()
100-GRAVIS-004

  • 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 BLACK BASE V2
In Commercial Distribution

  • 00045915829506 ()
100-GRAVIS-003

  • Bed/chair electric massager
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