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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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MAC Strap-Standard
Recovery Force, LLC
5
In Commercial Distribution

  • B547RF14208 ()
  • B547RF14200 ()
  • B547RF1440209 ()

  • Length: 565 Millimeter
RF1420

  • Intermittent venous compression system
XCELL PC Fluid Volume Reducer 120ml XC-PSPC-120
APEX BIOLOGIX , LLC
XC-PSPC-120
In Commercial Distribution

  • B708XCPSPC1201 ()
  • B708XCPSPC1200 ()
  • B708XCPSPC1202 ()


  • Haematological concentrate system preparation kit, platelet concentration
DRUGS OF ABUSE LEVEL 3
UTAK LABORATORIES, INC.
DAU 3 V2 F U VMG
In Commercial Distribution

  • B800DAU3V2FUVMG0 ()
  • B800DAU3V2FUVMG05 ()
  • B800DAU3V2FUVMG5 ()

  • Total Volume: 10 Milliliter
DAU 3 V2 F U VMG

  • Multiple drugs of abuse IVD, control
BUSULFAN 25 NG/ML
UTAK LABORATORIES, INC.
BUS 25 V P F CHLA
In Commercial Distribution

  • B800BUS25VPFCHLA5 ()
  • B800BUS25VPFCHLA0 ()
  • B800BUS25VPFCHLA55 ()

  • Total Volume: 5 Milliliter
BUS 25 V P F CHLA

  • Multiple-type clinical chemistry analyte profile IVD, control
BUS 250 V P F CHLA
UTAK LABORATORIES, INC.
BUS 250 V P F CHLA
In Commercial Distribution

  • B800BUS250VPFCHLA5 ()
  • B800BUS250VPFCHLA0 ()
  • B800BUS250VPFCHLA55 ()

  • Total Volume: 5 Milliliter
BUS 250 V P F CHLA

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN 10 NG/ML
UTAK LABORATORIES, INC.
BUS 10 V P F CHLA
In Commercial Distribution

  • B800BUS10VPFCHLA5 ()
  • B800BUS10VPFCHLA0 ()
  • B800BUS10VPFCHLA55 ()

  • Total Volume: 5 Milliliter
BUS 10 V P F CHLA

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN 100 NG/ML
UTAK LABORATORIES, INC.
BUS 100 V P F CHLA
In Commercial Distribution

  • B800BUS100VPFCHLA5 ()
  • B800BUS100VPFCHLA0 ()
  • B800BUS100VPFCHLA55 ()

  • Total Volume: 5 Milliliter
BUS 100 V P F CHLA

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN 1000 NG/ML
UTAK LABORATORIES, INC.
BUS 1000 V P F CHLA
In Commercial Distribution

  • B800BUS1000VPFCHLA5 ()
  • B800BUS1000VPFCHLA0 ()
  • B800BUS1000VPFCHLA55 ()

  • Total Volume: 5 Milliliter
BUS 1000 V P F CHLA

  • Multiple-type clinical chemistry analyte profile IVD, control
ACETONE BLANK
UTAK LABORATORIES, INC.
ACE BLK S F BSRHS
In Commercial Distribution

  • B800ACEBLKSFBSRHS5 ()
  • B800ACEBLKSFBSRHS0 ()
  • B800ACEBLKSFBSRHS55 ()

  • Total Volume: 1 Milliliter
ACE BLK S F BSRHS

  • Multiple-type clinical chemistry analyte profile IVD, control
Gelling fiber wound dressing, 4"x4"
IMBED BIOSCIENCES, INC
91002
Not in Commercial Distribution

  • B519910022 ()
  • B519910021 ()
  • B519910020 ()

  • Area/Surface Area: 16 Square inch
91002

  • Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial
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