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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Grael v2 System, no software
COMPUMEDICS LIMITED
Grael
In Commercial Distribution

  • 09342451001276 ()
9028-0001-02

  • Electroencephalograph
  • Polysomnograph
AIRFIT N30I SML STPK V2
RESMED PTY LTD
63839
In Commercial Distribution

  • 00619498638390 ()
63839

  • CPAP/BPAP nasal mask, reusable
AIRFIT N30I STD STPK V2
RESMED PTY LTD
63838
In Commercial Distribution

  • 00619498638383 ()
63838

  • CPAP/BPAP nasal mask, reusable
AIRTOUCH N30I SML STPK V2
RESMED PTY LTD
62309
In Commercial Distribution

  • 00619498623099 ()
62309

  • CPAP/BPAP nasal mask, reusable
AIRTOUCH N30I STD STPK V2
RESMED PTY LTD
62308
In Commercial Distribution

  • 00619498623082 ()
62308

  • CPAP/BPAP nasal mask, reusable
AMNIOTIC FLUID COLLECT KIT V2
MEDLINE INDUSTRIES, INC.
DYNJ59769
In Commercial Distribution

  • 10888277782747 ()
DYNJ59769

  • General surgical procedure kit, non-medicated, single-use
RETRACTOR HOLDER 9734119 HEADHOLDER V2
MEDTRONIC NAVIGATION, INC.
9734119
In Commercial Distribution

  • 00613994575463 ()


  • Extremity MRI system, permanent magnet
HEADGEAR CLIPS PKG V2 HEADGEAR
HANS RUDOLPH, INC.
7450
In Commercial Distribution

  • 00874750004010 ()
201555

  • Pulmonary function valve
ORTHOPILOT ACL V2 INSTRUMENT SET
Aesculap AG
FS860M
In Commercial Distribution

  • 04038653417780 ()
FS860M

  • Orthopaedic prosthesis implantation positioning instrument, reusable
CLOZAPINE 50 NG/ML V2
UTAK LABORATORIES, INC.
CLOZ 50 V2 UCI
In Commercial Distribution

  • B800CLOZ50V2UCI5 ()
  • B800CLOZ50V2UCI0 ()

  • Total Volume: 5 Milliliter
CLOZ 50 V2 UCI

  • Multiple-type clinical chemistry analyte profile IVD, control
CLOZAPINE 500 NG/ML V2
UTAK LABORATORIES, INC.
CLOZ 500 V2 UCI
In Commercial Distribution

  • B800CLOZ500V2UCI5 ()
  • B800CLOZ500V2UCI0 ()

  • Total Volume: 5 Milliliter
CLOZ 500 V2 UCI

  • Multiple-type clinical chemistry analyte profile IVD, control
CLOZAPINE 250 NG/ML V2
UTAK LABORATORIES, INC.
CLOZ 250 V2 UCI
In Commercial Distribution

  • B800CLOZ250V2UCI5 ()
  • B800CLOZ250V2UCI0 ()

  • Total Volume: 5 Milliliter
CLOZ 250 V2 UCI

  • Multiple-type clinical chemistry analyte profile IVD, control
CLOZAPINE 1000 NG/ML V2
UTAK LABORATORIES, INC.
CLOZ 1000 V2 UCI
In Commercial Distribution

  • B800CLOZ1000V2UCI5 ()
  • B800CLOZ1000V2UCI0 ()

  • Total Volume: 5 Milliliter
CLOZ 1000 V2 UCI

  • Multiple-type clinical chemistry analyte profile IVD, control
CCDKM QC LEVEL 1 V2
UTAK LABORATORIES, INC.
CCDKM QC 1 V2 WB UK
In Commercial Distribution

  • B800CCDKMQC1V2WBUK5 ()
  • B800CCDKMQC1V2WBUK0 ()

  • Total Volume: 3 Milliliter
CCDKM QC 1 V2 WB UK

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

  • B800BUSCAL3V2DPFMDACC5 ()
  • B800BUSCAL3V2DPFMDACC0 ()

  • Total Volume: 1.5 Milliliter
BUS CAL 3 V2 DP F MDACC

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

  • B800BUSCAL2V2DPFMDACC5 ()
  • B800BUSCAL2V2DPFMDACC0 ()

  • Total Volume: 1.5 Milliliter
BUS CAL 2 V2 DP F MDACC

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

  • B800BUSCAL1V2DPFMDACC5 ()
  • B800BUSCAL1V2DPFMDACC0 ()

  • Total Volume: 1.5 Milliliter
BUS CAL 1 V2 DP F MDACC

  • Multiple-type clinical chemistry analyte profile 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
ARACHIDIC ACID LEVEL 2 V2
UTAK LABORATORIES, INC.
ARA+ 2 V2 S ID
In Commercial Distribution

  • B800ARA2V2SID5 ()
  • B800ARA2V2SID0 ()

  • Total Volume: 3 Milliliter
ARA+ 2 V2 S ID

  • Multiple-type clinical chemistry analyte profile IVD, control
AMITRIPTYLINE PLUS LEVEL 2 V2
UTAK LABORATORIES, INC.
AMIT+ 2 V2 S SH
In Commercial Distribution

  • B800AMIT2V2SSH5 ()
  • B800AMIT2V2SSH0 ()

  • Total Volume: 3 Milliliter
AMIT+ 2 V2 S SH

  • Multiple-type clinical chemistry analyte profile IVD, control
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