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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TRICYCLICS LEVEL 2
UTAK LABORATORIES, INC.
TRIC 2 QDCHANT V2
In Commercial Distribution

  • B800TRIC2QDCHANTV25 ()
  • B800TRIC2QDCHANTV20 ()

  • Total Volume: 2 Milliliter
TRIC 2 QDCHANT V2

  • Multiple antidepressant therapeutic drug monitoring IVD, control
THIOCYANATE 15 MG/L
UTAK LABORATORIES, INC.
THIOC 15 V2 JH
In Commercial Distribution

  • B800THIOC15V2JH5 ()
  • B800THIOC15V2JH0 ()

  • Total Volume: 5 Milliliter
THIOC 15 V2 JH

  • Multiple-type clinical chemistry analyte profile IVD, control
NICOTINE URINE LEVEL 3
UTAK LABORATORIES, INC.
NICOU L3 V2 MAYO
In Commercial Distribution

  • B800NICOUL3V2MAYO5 ()
  • B800NICOUL3V2MAYO0 ()

  • Total Volume: 0.5 Milliliter
NICOU L3 V2 MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
NICOTINE URINE LEVEL 2
UTAK LABORATORIES, INC.
NICOU L2 V2 MAYO
In Commercial Distribution

  • B800NICOUL2V2MAYO5 ()
  • B800NICOUL2V2MAYO0 ()

  • Total Volume: 0.5 Milliliter
NICOU L2 V2 MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
NICOTINE URINE LEVEL 1
UTAK LABORATORIES, INC.
NICOU L1 V2 MAYO
In Commercial Distribution

  • B800NICOUL1V2MAYO5 ()
  • B800NICOUL1V2MAYO0 ()

  • Total Volume: 0.5 Milliliter
NICOU L1 V2 MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
LEFLUNOMIDE HIGH LEVEL 3
UTAK LABORATORIES, INC.
LEFLU HIGH L3 V2
In Commercial Distribution

  • B800LEFLUHIGHL3V25 ()
  • B800LEFLUHIGHL3V20 ()

  • Total Volume: 0.1 Milliliter
LEFLU HIGH L3 V2

  • Multiple drugs of abuse IVD, control
LEFLUNOMIDE HIGH LEVEL 2
UTAK LABORATORIES, INC.
LEFLU HIGH L2 V2
In Commercial Distribution

  • B800LEFLUHIGHL2V25 ()
  • B800LEFLUHIGHL2V20 ()

  • Total Volume: 0.1 Milliliter
LEFLU HIGH L2 V2

  • Multiple drugs of abuse IVD, control
LEFLUNOMIDE HIGH LEVEL 1
UTAK LABORATORIES, INC.
LEFLU HIGH L1 V2
In Commercial Distribution

  • B800LEFLUHIGHL1V25 ()
  • B800LEFLUHIGHL1V20 ()

  • Total Volume: 0.1 Milliliter
LEFLU HIGH L1 V2

  • Multiple drugs of abuse IVD, control
KIT DAU
UTAK LABORATORIES, INC.
KIT DAU V2 POTM
In Commercial Distribution

  • B800KITDAUV2POTM5 ()

  • Total Volume: 20 Milliliter
KIT DAU V2 POTM

  • Multiple-type clinical chemistry analyte profile IVD, control
IODINE 20 UG/L
UTAK LABORATORIES, INC.
IOD 20 V2 ADX
In Commercial Distribution

  • B800IOD20V2ADX5 ()
  • B800IOD20V2ADX0 ()

  • Total Volume: 10 Milliliter
IOD 20 V2 ADX

  • Multiple-type clinical chemistry analyte profile IVD, control
IODINE 200 UG/L
UTAK LABORATORIES, INC.
IOD 200 V2 ADX
In Commercial Distribution

  • B800IOD200V2ADX5 ()
  • B800IOD200V2ADX0 ()

  • Total Volume: 10 Milliliter
IOD 200 V2 ADX

  • Multiple-type clinical chemistry analyte profile IVD, control
IMMUNOASSAY LEVEL 3
UTAK LABORATORIES, INC.
IMMUNO 3 V2 ARUP
In Commercial Distribution

  • B800IMMUNO3V2ARUP0 ()

  • Total Volume: 5 Milliliter
IMMUNO 3 V2 ARUP

  • Multiple drugs of abuse IVD, control
IMMUNOASSAY LEVEL 2
UTAK LABORATORIES, INC.
IMMUNO 2 V2 ARUP
In Commercial Distribution

  • B800IMMUNO2V2ARUP5 ()
  • B800IMMUNO2V2ARUP0 ()

  • Total Volume: 5 Milliliter
IMMUNO 2 V2 ARUP

  • Multiple drugs of abuse IVD, control
IMMUNOASSAY LEVEL 1
UTAK LABORATORIES, INC.
IMMUNO 1 V2 ARUP
In Commercial Distribution

  • B800IMMUNO1V2ARUP5 ()
  • B800IMMUNO1V2ARUP0 ()

  • Total Volume: 5 Milliliter
IMMUNO 1 V2 ARUP

  • Multiple drugs of abuse IVD, control
DEFIBRINATED PLASMA
UTAK LABORATORIES, INC.
DP 5 V2 OVMC
In Commercial Distribution

  • B800DP5V2OVMC5 ()
  • B800DP5V2OVMC0 ()

  • Total Volume: 5 Milliliter
DP 5 V2 OVMC

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE
UTAK LABORATORIES, INC.
DAU V2 S SH
In Commercial Distribution

  • B800DAUV2SSH5 ()
  • B800DAUV2SSH0 ()

  • Total Volume: 3 Milliliter
DAU V2 S SH

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE LOW
UTAK LABORATORIES, INC.
DAU V2 LOW SER
In Commercial Distribution

  • B800DAUV2LOWSER5 ()
  • B800DAUV2LOWSER0 ()

  • Total Volume: 10 Milliliter
DAU V2 LOW SER

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE HIGH
UTAK LABORATORIES, INC.
DAU V2 HIGH SER
In Commercial Distribution

  • B800DAUV2HIGHSER5 ()
  • B800DAUV2HIGHSER0 ()

  • Total Volume: 10 Milliliter
DAU V2 HIGH SER

  • Multiple-type clinical chemistry analyte profile IVD, control
VISERA RHINO-LARYNGO VIDEOSCOPE
OLYMPUS MEDICAL SYSTEMS CORP.
OLYMPUS ENF TYPE V2
In Commercial Distribution

  • 04953170411342 ()


  • Flexible video laryngoscope
VISERA CYSTO-NEPHRO VIDEOSCOPE
OLYMPUS MEDICAL SYSTEMS CORP.
OLYMPUS CYF TYPE V2
In Commercial Distribution

  • 04953170411199 ()
N6005730

  • Flexible video cystonephroscope, reusable
CYF-V2 Flex CystoNephro Videoscope
OLYMPUS MEDICAL SYSTEMS CORP.
OLYMPUS CYF TYPE V2
Not in Commercial Distribution

  • 04953170339431 ()


  • Flexible video cystonephroscope, reusable
ENF-V2 Video Rhinolaryngoscope
OLYMPUS MEDICAL SYSTEMS CORP.
OLYMPUS ENF TYPE V2
Not in Commercial Distribution

  • 04953170291029 ()


  • Flexible video laryngoscope
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
OLYMPUS CYF TYPE V2
Not in Commercial Distribution

  • 04953170287091 ()


  • Flexible video cystonephroscope, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
122-22-4355
In Commercial Distribution

  • 09348215128272 ()


  • Surgical implant template, reusable
The 2M USB Magnetic Cable v2 Only Replacement Kit is a kit that may be shipped to users of the REVIAN Red device (Catalog #10001) who have lost or misplaced their Magnetic Micro-USB Cable originally supplied with the REVIAN Red Device.
Revian, Inc.
10000-12720
In Commercial Distribution

  • 00850003374116 ()
12720

  • Hair growth laser device
No Description
MICROSURGICAL TECHNOLOGY, INC.
BRT-1035-Y
In Commercial Distribution

  • 00844685004799 ()
BRT-1035-Y

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
No Description
MICROSURGICAL TECHNOLOGY, INC.
BRT-1035-G
In Commercial Distribution

  • 00844685004782 ()
BRT-1035-G

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
No Description
MICROSURGICAL TECHNOLOGY, INC.
BRT-1035-B
In Commercial Distribution

  • 00844685004775 ()
BRT-1035-B

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
No Description
MICROSURGICAL TECHNOLOGY, INC.
BRT-1034-Y
In Commercial Distribution

  • 00844685004768 ()
BRT-1034-Y

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
No Description
MICROSURGICAL TECHNOLOGY, INC.
BRT-1034-G
In Commercial Distribution

  • 00844685004751 ()
BRT-1034-G

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
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