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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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METALS LEVEL 1
UTAK LABORATORIES, INC.
MET T 1 WB UK
In Commercial Distribution

  • B80001696000011 ()
  • B80001696000010 ()
  • B80001696000012 ()
  • B80001696000013 ()
  • B80001696000016 ()
  • B80001696000017 ()
  • B80001696000018 ()


  • Multiple heavy metal IVD, control
No Description
UTAK LABORATORIES, INC.
U QC HIGH V2 EL
In Commercial Distribution

  • B80001390500040 ()
  • B80001390500041 ()
  • B80001390500042 ()
  • B80001390500043 ()
  • B80001390500046 ()
  • B80001390500047 ()
  • B80001390500048 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
No Description
UTAK LABORATORIES, INC.
U QC LOW V2 EL
In Commercial Distribution

  • B80001390500030 ()
  • B80001390500031 ()
  • B80001390500032 ()
  • B80001390500033 ()
  • B80001390500036 ()
  • B80001390500037 ()
  • B80001390500038 ()


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

  • B80001390500021 ()
  • B80001390500020 ()
  • B80001390500022 ()
  • B80001390500023 ()
  • B80001390500026 ()
  • B80001390500027 ()
  • B80001390500028 ()


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

  • B80001390500011 ()
  • B80001390500010 ()
  • B80001390500012 ()
  • B80001390500013 ()
  • B80001390500016 ()
  • B80001390500017 ()
  • B80001390500018 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
7-AMINO PLUS 100 NG/ML
UTAK LABORATORIES, INC.
7-AMINO+ 100 MP
In Commercial Distribution

  • B80000357500031 ()
  • B80000357500030 ()
  • B80000357500032 ()
  • B80000357500033 ()
  • B80000357500036 ()
  • B80000357500037 ()
  • B80000357500038 ()


  • Benzodiazepine group IVD, control
DAU +25% GCMS
UTAK LABORATORIES, INC.
DAU +25 GCMS
In Commercial Distribution

  • B80000357500021 ()
  • B80000357500020 ()
  • B80000357500022 ()
  • B80000357500023 ()
  • B80000357500026 ()
  • B80000357500027 ()
  • B80000357500028 ()


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

  • B80000357500011 ()
  • B80000357500010 ()
  • B80000357500012 ()
  • B80000357500013 ()
  • B80000357500016 ()
  • B80000357500017 ()
  • B80000357500018 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control
MAC Charger
Recovery Force, LLC
B
In Commercial Distribution

  • B547RF14300 ()
  • B547RF1440237 ()
  • B547RF1440207 ()
  • B547RF1440217 ()
  • B547RF1440227 ()
  • B547RF143009 ()

  • Length: 203 Millimeter
RF1430

  • Intermittent venous compression system
Sterile syringe delivery device used to deliver (inject) Volumex (Iodinated I-131Allbumin injection) for use in determinations of total blood and plasma volumes.
DAXOR CORPORATION
MAX-100 Syringe
In Commercial Distribution

  • B641MAX1004 ()
  • B641MAX1002 ()
  • B641MAX1000 ()
  • B641MAX1003 ()
  • B641MAX1001 ()
  • B641MAX1005 ()


  • Metered-delivery hypodermic syringe
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