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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/COC150/MET500/OPI300/THC50/(CR/OX/Ph)
ADVIN BIOTECH, INC.
ABCupD-05-02
In Commercial Distribution

  • B115ABCUPD05021 ()
  • B115ABCUPD05020 ()
ABCupD-05-02

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Colon Cleansing Nozzle with Flex Tube
LIFESTREAM PURIFICATION SYSTEM LLC
SP0001
In Commercial Distribution

  • B149SP00011 ()
  • B149SP0001 ()
  • SP00010 ()
SP0001

  • Colonic lavage nozzle, sterile
300 micrometer FlexGuard Fiber with Sheath Calculase compatible
OPTICAL INTEGRITY INC
27750300U1CFS
Not in Commercial Distribution

  • B14527750300U1C3FS1 ()
  • B14527750300U1CFS0 ()

  • Outer Diameter: 300 Micrometer
  • fiber core diameter


  • General/multiple surgical laser system beam guide, reusable
272 micrometer FlexGuard Fiber with Sheath Calculase compatible
OPTICAL INTEGRITY INC
27750272U1CFS
Not in Commercial Distribution

  • B14527750272U1C3FS1 ()
  • B14527750272U1CFS0 ()

  • Outer Diameter: 272 Micrometer
  • fiber core diameter


  • General/multiple surgical laser system beam guide, reusable
200 micrometer FlexGuard Fiber with Sheath Calculase compatible
OPTICAL INTEGRITY INC
27750200U1CFS
Not in Commercial Distribution

  • B14527750200U1C3FS1 ()
  • B14527750200U1CFS0 ()

  • Outer Diameter: 200 Micrometer
  • fiber core diameter


  • General/multiple surgical laser system beam guide, reusable
300 micrometer Flex-G Fiber with Sheath Calculase compatible
OPTICAL INTEGRITY INC
11098
In Commercial Distribution

  • B145111001 ()
  • B145110980 ()

  • Outer Diameter: 300 Micrometer
  • fiber core diameter


  • General/multiple surgical laser system beam guide, reusable
272 micrometer Flex-G Fiber with Sheath Calculase compatible
OPTICAL INTEGRITY INC
11094
In Commercial Distribution

  • B145110961 ()
  • B145110940 ()

  • fiber core diameter
  • Outer Diameter: 272 Micrometer


  • General/multiple surgical laser system beam guide, reusable
200 micrometer Flex-G Fiber with Sheath Calculase compatible
OPTICAL INTEGRITY INC
11090
In Commercial Distribution

  • B145110921 ()
  • B145110900 ()

  • fiber core diameter
  • Outer Diameter: 200 Micrometer


  • General/multiple surgical laser system beam guide, reusable
AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/TCA1000/THC50/(CR/OX/pH)
ADVIN BIOTECH, INC.
ABCupD-12-01
In Commercial Distribution

  • B115ABCUPD12011 ()
  • B115ABCUPD12010 ()
ABCupD-12-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/THC50/(CR/OX/Ph)
ADVIN BIOTECH, INC.
ABCupD-10-16
In Commercial Distribution

  • B115ABCUPD10161 ()
  • B115ABCUPD10160 ()
ABCupD-10-16

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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