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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HOLDER NDL NEEDLENEST V2
MEDLINE INDUSTRIES, INC.
DNSC126646
In Commercial Distribution

  • 40193489322775 ()
  • 10193489322774 ()
DNSC126646

  • General surgical procedure kit, non-medicated, single-use
SUPERFICIAL V2 PROCEDURE PK
MEDLINE INDUSTRIES, INC.
DYNJ82101
In Commercial Distribution

  • 40195327170586 ()
  • 10195327170585 ()
DYNJ82101

  • General surgical procedure kit, non-medicated, single-use
VENTX CONSOLE V2, 220V
SOLTA MEDICAL
110-0036
In Commercial Distribution

  • 00850608002520 ()
110-0036

  • Liposuction system
VASER AMPLIFIER V2, 220V
SOLTA MEDICAL
110-0035
In Commercial Distribution

  • 00850608002513 ()
110-0035

  • Ultrasonic surgical system generator
SRV KIT V2 WAM_UTK_LABEL
WELCH ALLYN, INC.
901095
In Commercial Distribution

  • 00732094326680 ()
108083

  • Electrocardiograph, professional, multichannel
KIT 9734024 PRF V2
MEDTRONIC NAVIGATION, INC.
9734024
In Commercial Distribution

  • 00613994532091 ()


  • Multi-purpose stereotactic surgery system
ARM 9734020 PRF V2
MEDTRONIC NAVIGATION, INC.
9734020
In Commercial Distribution

  • 00613994532053 ()


  • Multi-purpose stereotactic surgery system
GIBRALT,SET SCREW,V2
Choice Spine, LP
05-000-24-1000
In Commercial Distribution

  • 00840996170093 ()


  • Bone-screw internal spinal fixation system, non-sterile
IMPIX-TLIF THREADED ROD v2
MEDICREA INTERNATIONAL
A15130040
Not in Commercial Distribution

  • 03613720217503 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
MicroPort SmartView monitor V2+
MICROPORT CRM SRL
KC961
In Commercial Distribution

  • 08031527017877 ()
KC961

  • Medical networking interface unit
BUTALBITAL PLUS 3 V2
UTAK LABORATORIES, INC.
BUTALBITAL+ 3 V2 AP
In Commercial Distribution

  • B800BUTALBITAL3V2AP5 ()
  • B800BUTALBITAL3V2AP0 ()

  • Total Volume: 10 Milliliter
BUTALBITAL+ 3 V2 AP

  • Multiple-type clinical chemistry analyte profile IVD, control
BUTALBITAL PLUS 2 V2
UTAK LABORATORIES, INC.
BUTALBITAL+ 2 V2 AP
In Commercial Distribution

  • B800BUTALBITAL2V2AP5 ()
  • B800BUTALBITAL2V2AP0 ()

  • Total Volume: 10 Milliliter
BUTALBITAL+ 2 V2 AP

  • Multiple-type clinical chemistry analyte profile IVD, control
BUTALBITAL PLUS 1 V2
UTAK LABORATORIES, INC.
BUTALBITAL+ 1 V2 AP
In Commercial Distribution

  • B800BUTALBITAL1V2AP5 ()
  • B800BUTALBITAL1V2AP0 ()

  • Total Volume: 10 Milliliter
BUTALBITAL+ 1 V2 AP

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN LEVEL 2 V2
UTAK LABORATORIES, INC.
BUS 2 V2 P F EBS UK
In Commercial Distribution

  • B800BUS2V2PFEBSUK5 ()
  • B800BUS2V2PFEBSUK0 ()

  • Total Volume: 3 Milliliter
BUS 2 V2 P F EBS UK

  • Multiple-type clinical chemistry analyte profile IVD, control
BLANK WHOLE BLOOD V2
UTAK LABORATORIES, INC.
BLK WB V2 NJSP
In Commercial Distribution

  • B800BLKWBV2NJSP5 ()
  • B800BLKWBV2NJSP0 ()

  • Total Volume: 10 Milliliter
BLK WB V2 NJSP

  • Multiple-type clinical chemistry analyte profile IVD, control
66815 V2 HR LC
UTAK LABORATORIES, INC.
66815 V2 HR LC
In Commercial Distribution

  • B80066815V2HRLC5 ()
  • B80066815V2HRLC0 ()

  • Total Volume: 5 Milliliter
66815 V2 HR LC

  • Multiple-type clinical chemistry analyte profile IVD, control
PT SAMPLE 2019 V2
UTAK LABORATORIES, INC.
PT 2019 UTAK V2
In Commercial Distribution

  • B800PT2019UTAKV25 ()
  • B800PT2019UTAKV20 ()

  • Total Volume: 25 Milliliter
PT 2019 UTAK V2

  • Multiple-type clinical chemistry analyte profile IVD, control
HMSB LEVEL 3 V2
UTAK LABORATORIES, INC.
HMSB 3 V2 WB F MAYO
In Commercial Distribution

  • B800HMSB3V2WBFMAYO5 ()
  • B800HMSB3V2WBFMAYO0 ()

  • Total Volume: 5 Milliliter
HMSB 3 V2 WB F MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
GLUCURONIDES HYDROLYSIS QC V2
UTAK LABORATORIES, INC.
GLUC QC V2 U CCHS
In Commercial Distribution

  • B800GLUCQCV2UCCHS5 ()
  • B800GLUCQCV2UCCHS0 ()

  • Total Volume: 5 Milliliter
GLUC QC V2 U CCHS

  • Multiple-type clinical chemistry analyte profile IVD, control
GABAPENTIN LEVEL 3 V2
UTAK LABORATORIES, INC.
GABA 3 V2 SMXU F PG
In Commercial Distribution

  • B800GABA3V2SMXUFPG5 ()
  • B800GABA3V2SMXUFPG0 ()

  • Total Volume: 2 Milliliter
GABA 3 V2 SMXU F PG

  • Multiple-type clinical chemistry analyte profile IVD, control
GABAPENTIN LEVEL 1 V2
UTAK LABORATORIES, INC.
GABA 1 V2 SMXU F PG
In Commercial Distribution

  • B800GABA1V2SMXUFPG5 ()
  • B800GABA1V2SMXUFPG0 ()

  • Total Volume: 2 Milliliter
GABA 1 V2 SMXU F PG

  • Multiple-type clinical chemistry analyte profile IVD, control
DAU LEVEL 2 V2
UTAK LABORATORIES, INC.
DAU 2 V2 UCSD
In Commercial Distribution

  • B800DAU2V2UCSD5 ()
  • B800DAU2V2UCSD0 ()

  • Total Volume: 1.2 Milliliter
DAU 2 V2 UCSD

  • Multiple drugs of abuse IVD, control
DAU LEVEL 1 V2
UTAK LABORATORIES, INC.
DAU 1 V2 UCSD
In Commercial Distribution

  • B800DAU1V2UCSD5 ()
  • B800DAU1V2UCSD0 ()

  • Total Volume: 1.2 Milliliter
DAU 1 V2 UCSD

  • Multiple drugs of abuse IVD, control
PETH LEVEL 7 V2
UTAK LABORATORIES, INC.
PETH 7 V2 WB F HFHS
In Commercial Distribution

  • B800PETH7V2WBFHFHS5 ()
  • B800PETH7V2WBFHFHS0 ()

  • Total Volume: 2 Milliliter
PETH 7 V2 WB F HFHS

  • Multiple drugs of abuse IVD, control
PETH LEVEL 6 V2
UTAK LABORATORIES, INC.
PETH 6 V2 WB F HFHS
In Commercial Distribution

  • B800PETH6V2WBFHFHS5 ()
  • B800PETH6V2WBFHFHS0 ()

  • Total Volume: 2 Milliliter
PETH 6 V2 WB F HFHS

  • Multiple drugs of abuse IVD, control
PETH LEVEL 5 V2
UTAK LABORATORIES, INC.
PETH 5 V2 WB F HFHS
In Commercial Distribution

  • B800PETH5V2WBFHFHS5 ()
  • B800PETH5V2WBFHFHS0 ()

  • Total Volume: 2 Milliliter
PETH 5 V2 WB F HFHS

  • Multiple drugs of abuse IVD, control
PETH LEVEL 4 V2
UTAK LABORATORIES, INC.
PETH 4 V2 WB F HFHS
In Commercial Distribution

  • B800PETH4V2WBFHFHS5 ()
  • B800PETH4V2WBFHFHS0 ()

  • Total Volume: 2 Milliliter
PETH 4 V2 WB F HFHS

  • Multiple drugs of abuse IVD, control
PETH LEVEL 3 V2
UTAK LABORATORIES, INC.
PETH 3 V2 WB F HFHS
In Commercial Distribution

  • B800PETH3V2WBFHFHS5 ()
  • B800PETH3V2WBFHFHS0 ()

  • Total Volume: 2 Milliliter
PETH 3 V2 WB F HFHS

  • Multiple drugs of abuse IVD, control
PETH LEVEL 2 V2
UTAK LABORATORIES, INC.
PETH 2 V2 WB F HFHS
In Commercial Distribution

  • B800PETH2V2WBFHFHS5 ()
  • B800PETH2V2WBFHFHS0 ()

  • Total Volume: 2 Milliliter
PETH 2 V2 WB F HFHS

  • Multiple drugs of abuse IVD, control
PETH LEVEL 1 V2
UTAK LABORATORIES, INC.
PETH 1 V2 WB F HFHS
In Commercial Distribution

  • B800PETH1V2WBFHFHS5 ()
  • B800PETH1V2WBFHFHS0 ()

  • Total Volume: 2 Milliliter
PETH 1 V2 WB F HFHS

  • Multiple drugs of abuse IVD, control
OPIATES LEVEL 2 V2
UTAK LABORATORIES, INC.
OPIA 2 V2 U F CRL
In Commercial Distribution

  • B800OPIA2V2UFCRL5 ()
  • B800OPIA2V2UFCRL0 ()

  • Total Volume: 100 Milliliter
OPIA 2 V2 U F CRL

  • Multiple-type clinical chemistry analyte profile IVD, control
OPIATES LEVEL 1 V2
UTAK LABORATORIES, INC.
OPIA 1 V2 U F CRL
In Commercial Distribution

  • B800OPIA1V2UFCRL5 ()
  • B800OPIA1V2UFCRL0 ()

  • Total Volume: 100 Milliliter
OPIATES LEVEL 1 V2

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

  • B800OPATL3V2MAYO5 ()
  • B800OPATL3V2MAYO0 ()

  • Total Volume: 1 Milliliter
OPAT L3 V2 MAYO

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

  • B800OPATL2V2MAYO5 ()
  • B800OPATL2V2MAYO0 ()

  • Total Volume: 1 Milliliter
OPAT L2 V2 MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
ETHANOL BI-LEVEL SET V2
UTAK LABORATORIES, INC.
ETH SET V2 WB CRL
In Commercial Distribution

  • B800ETHSETV2WBCRL5 ()
  • B800ETHSETV2WBCRL0 ()

  • Total Volume: 3 Milliliter
ETH SET V2 WB CRL

  • Multiple-type clinical chemistry analyte profile IVD, control
DAU+ V2 F OT
UTAK LABORATORIES, INC.
URINE PAIN PANEL
In Commercial Distribution

  • B800DAUV2FOT5 ()
  • B800DAUV2FOT0 ()

  • Total Volume: 1 Milliliter
URINE PAIN PANEL

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN LEVEL 3 V2
UTAK LABORATORIES, INC.
BUS 3 V2 P F NIH
In Commercial Distribution

  • B800BUS3V2PFNIH5 ()
  • B800BUS3V2PFNIH0 ()

  • Total Volume: 50 Milliliter
BUS 3 V2 P F NIH

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN LEVEL 3 V2
UTAK LABORATORIES, INC.
BUS 3 V2 P F EBS UK
In Commercial Distribution

  • B800BUS3V2PFEBSUK0 ()
  • B800BUS3V2PFEBSUK5 ()

  • Total Volume: 3 Milliliter
BUS 3 V2 P F EBS UK

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN LEVEL 2 V2
UTAK LABORATORIES, INC.
BUS 2 V2 P F NIH
In Commercial Distribution

  • B800BUS2V2PFNIH5 ()
  • B800BUS2V2PFNIH0 ()

  • Total Volume: 50 Milliliter
BUS 2 V2 P F NIH

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN LEVEL 1 V2
UTAK LABORATORIES, INC.
BUS 1 V2 P F NIH
In Commercial Distribution

  • B800BUS1V2PFNIH0 ()

  • Total Volume: 50 Milliliter
BUS 1 V2 P F NIH

  • Multiple-type clinical chemistry analyte profile IVD, control
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