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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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AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI2000/OXY100/PCP25/THC50/Ox/SG/pH/Cr/Ni/Gl
ADVIN BIOTECH, INC.
ABCardC-12-71
In Commercial Distribution

  • B115ABCARDC12710 ()
  • B115ABCARDC12711 ()
ABCardC-12-71

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/PPX300/THC50/Ox/SG/pH/Cr/Ni/Gl
ADVIN BIOTECH, INC.
ABCardC-12-44
In Commercial Distribution

  • B115ABCARDC12440 ()
  • B115ABCARDC12441 ()
ABCardC-12-44

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
BZO300/COC150/MET500/OPI300/OXY100/PCP25/THC50/(Ox/SG/pH)/(Cr/Ni/Gl)
ADVIN BIOTECH, INC.
ABCardC-07-43
In Commercial Distribution

  • B115ABCARDC07430 ()
  • B115ABCARDC07431 ()
ABCardC-07-43

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BZO300/COC150/MET500/OPI300/OXY100/THC50/(Ox/SG/pH)/(Cr/Ni/Gl)
ADVIN BIOTECH, INC.
ABCardC-07-03
In Commercial Distribution

  • B115ABCARDC07031 ()
  • B115ABCARDC07030 ()
ABCardC-07-03

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/TCA1000/THC50/(OX/pH/SG)
ADVIN BIOTECH, INC.
ABCardA-11-39
In Commercial Distribution

  • B115ABCARDA11390 ()
  • B115ABCARDA11391 ()
ABCardA-11-39

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
JHook with Cable 8 mm Plug
ORANGE SURGICAL INSTRUMENTS, LLC
OSJHOOK445C
Not in Commercial Distribution

  • B354OSJHOOK445C10 ()
  • B354OSJHOOK445C0 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
Lap Port Closure Device with Swabs
ORANGE SURGICAL INSTRUMENTS, LLC
OSLPCDS
In Commercial Distribution

  • B35400 ()
  • B354OSLPCDS9 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
Lap Port Closure Device with Swabs
ORANGE SURGICAL INSTRUMENTS, LLC
OSLPCDS
In Commercial Distribution

  • B35400 ()
  • B354OSLPCDS5 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
Lap Port Closure Device with Swabs
ORANGE SURGICAL INSTRUMENTS, LLC
OSLPCDS
In Commercial Distribution

  • B35400 ()
  • B354OSLPCDS4 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
Lap Port Closure Device with Swabs
ORANGE SURGICAL INSTRUMENTS, LLC
OSLPCDS
In Commercial Distribution

  • B35400 ()
  • B354OSLPCDS3 ()


  • Endoscopic electrosurgical electrode, monopolar, single-use
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