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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Screw Set, LiDCOunity V2
LIDCO LIMITED
Li11169
In Commercial Distribution

  • 05060110522774 ()
Li11169

  • General-purpose multi-parameter bedside monitor
Accessory Pack, LiDCOrapid, v2
LIDCO LIMITED
Li10791
In Commercial Distribution

  • 05060110521562 ()
Li10791

  • General-purpose multi-parameter bedside monitor
STELLAR Knee Application, V2
POLARISAR, INC.
Software Version 2.0.107
In Commercial Distribution

  • 00850046497131 ()
70-0003

  • Orthopaedic stereotactic surgery system
MAF v2 Probe Red
CYTOCELL LIMITED
LPH567-A
In Commercial Distribution

  • 05055844904545 ()
LPH567-A

  • Assay development analyte-specific reagent IVD
Somte PSG v2 Assembly
COMPUMEDICS LIMITED
Somte PSG v2
In Commercial Distribution

  • 09342451001382 ()
8023-0001-02

  • Polysomnograph
Grael EEG v2 Assembly
COMPUMEDICS LIMITED
Grael EEG
In Commercial Distribution

  • 09342451001238 ()
8028-0002-02

  • Electroencephalograph
Neuvo Event Button V2
COMPUMEDICS LIMITED
Neuvo Event Button V2
In Commercial Distribution

  • 09342451001030 ()
8022-0018-02

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

  • 40193489322775 ()
  • 10193489322774 ()
DNSC126646

  • General surgical procedure kit, non-medicated, single-use
TROCAR VERSAPORT PLUS V2
STERILMED, INC.
AUT179095P
Not in Commercial Distribution

  • 10888551013161 ()
AUT179095P

  • Laparoscopic trocar blade, reprocessed
TROCAR VERSAPORT PLUS V2
STERILMED, INC.
AUT179094
Not in Commercial Distribution

  • 10888551013147 ()
AUT179094

  • Laparoscopic trocar blade, reprocessed
ALGORITHM SERVICES EK12 V2
Ge Medical Systems Information Technologies, Inc.
EK12 V2
In Commercial Distribution

  • 00195278457547 ()
2104498-003

  • Cardiology information system application software
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 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 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
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
BUSULFAN LEVEL 1 V2
UTAK LABORATORIES, INC.
BUS 1 V2 P F EBS UK
In Commercial Distribution

  • B800BUS1V2PFEBSUK5 ()
  • B800BUS1V2PFEBSUK0 ()

  • Total Volume: 3 Milliliter
BUS 1 V2 P F EBS UK

  • Multiple-type clinical chemistry analyte profile IVD, control
BENZODIAZEPINES LEVEL 2 V2
UTAK LABORATORIES, INC.
BENZO L2 V2 U F UW
In Commercial Distribution

  • B800BENZOL2V2UFUW5 ()
  • B800BENZOL2V2UFUW0 ()

  • Total Volume: 1 Milliliter
BENZO L2 V2 U F UW

  • Multiple-type clinical chemistry analyte profile IVD, control
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