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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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CBAM LEVEL 2
UTAK LABORATORIES, INC.
CBAM 2 V4 MAYO
In Commercial Distribution

  • B800CBAM2V4MAYO5 ()
  • B800CBAM2V4MAYO0 ()

  • Total Volume: 5 Milliliter
CBAM 2 V4 MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
CANNABINOIDS CALIBRATOR 2
UTAK LABORATORIES, INC.
CANN CAL 2 U IMMU
In Commercial Distribution

  • B800CANNCAL2UIMMU0 ()

  • Total Volume: 4 Milliliter
CANN CAL 2 U IMMU

  • Multiple drugs of abuse IVD, control
CANNABINOIDS LEVEL 2
UTAK LABORATORIES, INC.
CAN 2 S F UWMC
In Commercial Distribution

  • B800CAN2SFUWMC5 ()
  • B800CAN2SFUWMC0 ()

  • Total Volume: 0.5 Milliliter
CAN 2 S F UWMC

  • Multiple drugs of abuse IVD, control
BUSULFAN LEVEL 2
UTAK LABORATORIES, INC.
BUS 2 P F EBS UK
In Commercial Distribution

  • B800BUS2PFEBSUK5 ()
  • B800BUS2PFEBSUK0 ()

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

  • Multiple drugs of abuse IVD, control
BUSULFAN LEVEL 2
UTAK LABORATORIES, INC.
BUS 2 DP UPMC
In Commercial Distribution

  • B800BUS2DPUPMC5 ()
  • B800BUS2DPUPMC0 ()

  • Total Volume: 0.5 Milliliter
BUS 2 DP UPMC

  • Multiple-therapy therapeutic drug monitoring IVD, control
BUSULFAN LEVEL 2
UTAK LABORATORIES, INC.
BUS 2 DP F DU
In Commercial Distribution

  • B800BUS2DPFDU5 ()
  • B800BUS2DPFDU0 ()

  • Total Volume: 1 Milliliter
BUS 2 DP F DU

  • Multiple-therapy therapeutic drug monitoring IVD, control
AVEA VENTILATOR
VYAIRE MEDICAL, INC.
32029-001
Not in Commercial Distribution

  • 10846446066074 ()
32029-001

  • Neonatal/adult intensive-care ventilator
DB BKT SL EMPOWER PASSIVE LR 2ND BICUSPID 018 T-17 A+2 R=0 BX PAD
AMERICAN ORTHODONTICS CORPORATION
575-18-94517
In Commercial Distribution

  • 00190746134104 ()
575-18-94517

  • Orthodontic bracket, metal
WELD TUBE SL EMPOWER LL 1ST MOLAR 018 SLOT T=0 A=0 R=0 W/HK MES
AMERICAN ORTHODONTICS CORPORATION
008-18-360H
Not in Commercial Distribution

  • 00190746132353 ()
008-18-360H

  • Orthodontic tube
Gun, Dispenser, 4:1
Zest Anchors, LLC
90176
In Commercial Distribution

  • 00840481133626 ()


  • Dental material application tool, single-use
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