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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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
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
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
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
JAZZ – Open Braid V2
IMPLANET
JAZZ – Open Braid V2
In Commercial Distribution

  • 03607503501583 ()
350158

  • Trans-facet-screw internal spinal fixation system, sterile
Quadra instruments tray V2
Medacta International SA
01.10.10.0076
In Commercial Distribution

  • 07630040739405 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
AMIStem Broach v2 #9
Medacta International SA
01.18.10.419
In Commercial Distribution

  • 07630040745574 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
AMIStem Broach v2 #8
Medacta International SA
01.18.10.418
In Commercial Distribution

  • 07630040745567 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
AMIStem Broach v2 #7
Medacta International SA
01.18.10.417
In Commercial Distribution

  • 07630040745550 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
AMIStem Broach v2 #6
Medacta International SA
01.18.10.416
In Commercial Distribution

  • 07630040745543 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
AMIStem Broach v2 #5
Medacta International SA
01.18.10.415
In Commercial Distribution

  • 07630040745536 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
AMIStem Broach v2 #4
Medacta International SA
01.18.10.414
In Commercial Distribution

  • 07630040745529 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
AMIStem Broach v2 #3
Medacta International SA
01.18.10.413
In Commercial Distribution

  • 07630040745512 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
AMIStem Broach v2 #2
Medacta International SA
01.18.10.412
In Commercial Distribution

  • 07630040745505 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
AMIStem Broach v2 #1
Medacta International SA
01.18.10.411
In Commercial Distribution

  • 07630040745499 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
AMIStem Broach v2 #0
Medacta International SA
01.18.10.410
In Commercial Distribution

  • 07630040745482 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
AMIStem Broach v2 #00
Medacta International SA
01.18.10.409
In Commercial Distribution

  • 07630040745475 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
AMIStem instruments tray V2
Medacta International SA
01.18.10.403
In Commercial Distribution

  • 07630040745468 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Quadra Broach v2 #10
Medacta International SA
01.10.10.0640
In Commercial Distribution

  • 07630040741538 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Quadra Broach v2 #9
Medacta International SA
01.10.10.0639
In Commercial Distribution

  • 07630040741514 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Quadra Broach v2 #8
Medacta International SA
01.10.10.0638
In Commercial Distribution

  • 07630040741507 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Minimax instruments tray V2
Medacta International SA
01.13.10.4002
In Commercial Distribution

  • 07630040783552 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
AMIS instruments tray V2
Medacta International SA
01.15.10.0106
In Commercial Distribution

  • 07630040768603 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
SMS instruments tray V2
Medacta International SA
01.36.10.0301
In Commercial Distribution

  • 07630040760805 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Masterloc instruments tray V2
Medacta International SA
01.39.10.0301
In Commercial Distribution

  • 07630040763912 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
M.U.S.T. Fenestrated Tray V2
Medacta International SA
03.51.10.0303
In Commercial Distribution

  • 07630971266247 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Neck Brace (Beige) V2
VIVE HEALTH LLC
SUP1032BGE
In Commercial Distribution

  • 10818323027645 ()
  • 00818323027648 ()


  • Cervical spine collar, reusable
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
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