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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ACC. ME IRIC CHARGER V2
Ws Audiology Usa, Inc.
MECHARGE iRIC Charger v2
In Commercial Distribution

  • 05714880161472 ()
21014782

  • Noninvasive device battery charger
RETRACTOR HOLDER 9734119 HEADHOLDER V2
MEDTRONIC NAVIGATION, INC.
9734119
In Commercial Distribution

  • 00613994575463 ()


  • Extremity MRI system, permanent magnet
GIBRALT,CONNECTOR,SET SCREW,V2
Choice Spine, LP
05-000-24-2000
In Commercial Distribution

  • 00840996170109 ()


  • Bone-screw internal spinal fixation system, non-sterile
Syphilis Elecsys E2G 300 V2
Roche Diagnostics GmbH
09015051190
In Commercial Distribution

  • 07613336171998 ()
09015051190

  • Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay
BUSULFAN CALIBRATOR LEVEL 6 V2
UTAK LABORATORIES, INC.
BUS CAL 6 V2 DP F MDACC
In Commercial Distribution

  • B800BUSCAL6V2DPFMDACC5 ()
  • B800BUSCAL6V2DPFMDACC0 ()

  • Total Volume: 1.5 Milliliter
BUS CAL 6 V2 DP F MDACC

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN CALIBRATOR LEVEL 5 V2
UTAK LABORATORIES, INC.
BUS CAL 5 V2 DP F MDACC
In Commercial Distribution

  • B800BUSCAL5V2DPFMDACC5 ()
  • B800BUSCAL5V2DPFMDACC0 ()

  • Total Volume: 1.5 Milliliter
BUS CAL 5 V2 DP F MDACC

  • Multiple-type clinical chemistry analyte profile IVD, control
BUPRENORPHINE PLUS LEVEL 3 V2
UTAK LABORATORIES, INC.
BUP+ 3 V2 U F MAYO
In Commercial Distribution

  • B800BUP3V2UFMAYO5 ()
  • B800BUP3V2UFMAYO0 ()

  • Total Volume: 1 Milliliter
BUP+ 3 V2 U F MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
BUPRENORPHINE PLUS LEVEL 2 V2
UTAK LABORATORIES, INC.
BUP+ 2 V2 U KP
In Commercial Distribution

  • B800BUP2V2UKP5 ()
  • B800BUP2V2UKP0 ()

  • Total Volume: 1 Milliliter
BUP+ 2 V2 U KP

  • Multiple drugs of abuse IVD, control
BUPRENORPHINE PLUS LEVEL 2 V2
UTAK LABORATORIES, INC.
BUP+ 2 V2 U F MAYO
In Commercial Distribution

  • B800BUP2V2UFMAYO5 ()
  • B800BUP2V2UFMAYO0 ()

  • Total Volume: 1 Milliliter
BUP+ 2 V2 U F MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
BUPRENORPHINE PLUS LEVEL 1 V2
UTAK LABORATORIES, INC.
BUP+ 1 V2 U F MAYO
In Commercial Distribution

  • B800BUP1V2UFMAYO5 ()
  • B800BUP1V2UFMAYO0 ()

  • Total Volume: 1 Milliliter
BUP+ 1 V2 U F MAYO

  • Multiple-type clinical chemistry analyte profile IVD, control
ANABASINE PLUS LEVEL 2 V2
UTAK LABORATORIES, INC.
ANAB+ 2 V2 U LC
In Commercial Distribution

  • B800ANAB2V2ULC5 ()
  • B800ANAB2V2ULC0 ()

  • Total Volume: 5 Milliliter
ANAB+ 2 V2 U LC

  • Multiple-type clinical chemistry analyte profile IVD, control
ANABASINE PLUS LEVEL 1 V2
UTAK LABORATORIES, INC.
ANAB+ 1 V2 U LC
In Commercial Distribution

  • B800ANAB1V2ULC5 ()
  • B800ANAB1V2ULC0 ()

  • Total Volume: 5 Milliliter
ANAB+ 1 V2 U LC

  • Multiple-type clinical chemistry analyte profile IVD, control
NORMAL RANGE TRACE ELEMENTS V2
UTAK LABORATORIES, INC.
66816 NR V2 LC
In Commercial Distribution

  • B80066816NRV2LC5 ()
  • B80066816NRV2LC0 ()

  • Total Volume: 5 Milliliter
66816 NR V2 LC

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

  • B80066815HRV2LC0 ()

  • Total Volume: 5 Milliliter
66815 HR V2 LC

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

  • B800LEFLUV2LL35 ()
  • B800LEFLUV2LL30 ()

  • Total Volume: .5 Milliliter
LEFLU V2 L L3

  • Multiple-type clinical chemistry analyte profile IVD, control
LEFLUNOMIDE V2 LOW LEVEL 2
UTAK LABORATORIES, INC.
LEFLU V2 L L2
In Commercial Distribution

  • B800LEFLUV2LL25 ()
  • B800LEFLUV2LL20 ()

  • Total Volume: .5 Milliliter
LEFLU V2 L L2

  • Multiple-type clinical chemistry analyte profile IVD, control
LEFLUNOMIDE V2 LOW LEVEL 1
UTAK LABORATORIES, INC.
LEFLU V2 L L1
In Commercial Distribution

  • B800LEFLUV2LL15 ()
  • B800LEFLUV2LL10 ()

  • Total Volume: .5 Milliliter
LEFLU V2 L L1

  • Multiple-type clinical chemistry analyte profile IVD, control
SERUM DRUGS LEVEL 2 V2
UTAK LABORATORIES, INC.
DRUGS 2 V2 S SH
In Commercial Distribution

  • B800DRUGS2V2SSH5 ()
  • B800DRUGS2V2SSH0 ()

  • Total Volume: 3 Milliliter
DRUGS 2 V2 S SH

  • Multiple-type clinical chemistry analyte profile IVD, control
SERUM DRUGS LEVEL 1 V2
UTAK LABORATORIES, INC.
DRUGS 1 V2 S SH
In Commercial Distribution

  • B800DRUGS1V2SSH5 ()
  • B800DRUGS1V2SSH0 ()

  • Total Volume: 3 Milliliter
DRUGS 1 V2 S SH

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

  • B800DAUMIDV2FPG5 ()
  • B800DAUMIDV2FPG0 ()

  • Total Volume: 2 Milliliter
DAU MID V2 F PG

  • Multiple-type clinical chemistry analyte profile IVD, control
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