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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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OSTEOTOME N 2
Sin Sistema de Implante Nacional S/A
OST 02
In Commercial Distribution

  • 07899995254481 ()
OST 02

  • Dental osteotome
ADULTERANT LEVEL 2
UTAK LABORATORIES, INC.
ADULT 2 U KP
In Commercial Distribution

  • B800ADULT2UKP5 ()
  • B800ADULT2UKP0 ()

  • Total Volume: 10 Milliliter
ADULT 2 U KP

  • Multiple-type clinical chemistry analyte profile IVD, control
6-MONOACETYLMORPHINE LEVEL 2
UTAK LABORATORIES, INC.
6-MAM 2 OF NAVIS
In Commercial Distribution

  • B8006MAM2OFNAVIS5 ()
  • B8006MAM2OFNAVIS0 ()

  • Total Volume: 1.5 Milliliter
6-MAM 2 OF NAVIS

  • Multiple-type clinical chemistry analyte profile IVD, control
DAU LC 2
UTAK LABORATORIES, INC.
50703
In Commercial Distribution

  • B800507035 ()
  • B800507030 ()

  • Total Volume: 10 Milliliter
50703

  • Multiple drugs of abuse IVD, control
BUSULFAN LEVEL 2
UTAK LABORATORIES, INC.
BUS 2 P F UK
In Commercial Distribution

  • B80001696000081 ()
  • B80001696000080 ()
  • B80001696000082 ()
  • B80001696000083 ()
  • B80001696000086 ()
  • B80001696000087 ()
  • B80001696000088 ()


  • Busulfan therapeutic drug monitoring IVD, control
METALS LEVEL 2
UTAK LABORATORIES, INC.
MET T 2 DP UK
In Commercial Distribution

  • B80001696000041 ()
  • B80001696000040 ()
  • B80001696000042 ()
  • B80001696000043 ()
  • B80001696000046 ()
  • B80001696000047 ()
  • B80001696000048 ()


  • Multiple heavy metal IVD, control
METALS LEVEL 2
UTAK LABORATORIES, INC.
MET T 2 WB UK
In Commercial Distribution

  • B80001696000021 ()
  • B80001696000020 ()
  • B80001696000022 ()
  • B80001696000023 ()
  • B80001696000026 ()
  • B80001696000027 ()
  • B80001696000028 ()


  • Multiple heavy metal IVD, control
No Description
ZATTY INDUSTRIA COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTACAO CIRURGICA E ODONTOLOGICA LTDA
302
In Commercial Distribution

  • 07898588840087 ()


  • Orthodontic pliers
AMIODARONE LEVEL 2
UTAK LABORATORIES, INC.
AMIO 2 S F QDVA
In Commercial Distribution

  • B800AMIO2SFQDVA5 ()
  • B800AMIO2SFQDVA0 ()

  • Total Volume: 5 Milliliter
AMIO 2 S F QDVA

  • Multiple-type clinical chemistry analyte profile IVD, control
ALUMINUM LEVEL 2
UTAK LABORATORIES, INC.
ALUM 2 S BP
In Commercial Distribution

  • B800ALUM2SBP5 ()
  • B800ALUM2SBP0 ()

  • Total Volume: 3 Milliliter
ALUM 2 S BP

  • Multiple-type clinical chemistry analyte profile IVD, control
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