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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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RANFAC BREAST MRK, 7.5CM F/G SBS-7.5 PN 60004-03M
RANFAC CORP.
7.5 CM
In Commercial Distribution

  • M9796000403M9 ()
  • M9796000403M1 ()
  • M9796000403M0 ()

  • Length: 7.5 Centimeter
SBS-7.5

  • Needle guide, single-use
RANFAC BREAST MRK, 10CM F/G SBS-10 PN 60004-02M
RANFAC CORP.
10CM
In Commercial Distribution

  • M9796000402M9 ()
  • M9796000402M1 ()
  • M9796000402M0 ()

  • Length: 10 Centimeter
SBS-10

  • Needle guide, single-use
RANFAC BREAST MRK, 5CM F/G SBS-5 PN 60004-01M
RANFAC CORP.
5CM
In Commercial Distribution

  • M9796000401M9 ()
  • M9796000401M1 ()
  • M9796000401M0 ()

  • Length: 5 Centimeter
SBS-5

  • Needle guide, single-use
1200 PSI High Pressure Y-Line with Rotating Adapter
COEUR, INC.
C453-2420
In Commercial Distribution

  • M902124206 ()
  • M902124205 ()
  • M902124200 ()
C453-2420

  • Radiographic procedure tubing
60” (1500mm) 330psi Coiled Connector Tube
COEUR, INC.
C455-0060
In Commercial Distribution

  • M902100606 ()
  • M902100605 ()
  • M902100600 ()

  • Length: 60 Inch
C455-0060

  • Radiographic procedure tubing
QuickProfile™ 2019-nCoV IgG/IgM Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of IgG and IgM antibodies to the 2019 novel coronavirus (2019-nCoV, SARS-CoV-2) in human serum, plasma, or whole blood. QuickProfile™ 2019-nCoV IgG/IgM Test Card is a supplemental rapid screening tool for symptomatic or asymptomatic carriers of the virus.
LUMIQUICK DIAGNOSTICS, INC.
71108B
In Commercial Distribution

  • M90171108B1 ()
  • M90171108B0 ()
  • M90171108B2 ()

  • Length: 80 Millimeter
71108B

  • SARS-CoV-2 immunoglobulin G (IgG)/IgM antibody IVD, kit, rapid ICT, clinical
Immunoassay for the detection of oxycodone in human urine
LUMIQUICK DIAGNOSTICS, INC.
07RD7101
In Commercial Distribution

  • M90107RD71011 ()
  • M90107RD71010 ()
  • M90107RD71012 ()

  • Length: 75 Millimeter
07RD7101

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: BZD / COC / M-AMP / OPI / OXY / MTD
LUMIQUICK DIAGNOSTICS, INC.
07RD7065-39
In Commercial Distribution

  • M90107RD7065391 ()
  • M90107RD7065390 ()
  • M90107RD7065392 ()

  • Length: 75 Millimeter
07RD7065-39

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Immunoassay for the detection of the following drug substance(s) in human urine: AMP / BZD / COC/ OPI / THC
LUMIQUICK DIAGNOSTICS, INC.
07RD7064-05
In Commercial Distribution

  • M90107RD7064051 ()
  • M90107RD7064050 ()
  • M90107RD7064052 ()

  • Length: 75 Millimeter
07RD7064-05

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Utopia HV Face Mask - Large
Innomed Technologies Inc
LG
In Commercial Distribution

  • M694UTO2955 ()
  • M694UTO2953 ()
  • M694UTO2951 ()
UTO295

  • CPAP/BPAP face mask, reusable
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