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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EVI1 (MECOM) Breakapart FISH Probe Kit
CYTOCELL LIMITED
USA-LPH036
In Commercial Distribution

  • 05055844901582 ()
USA-LPH036

  • Myelodysplastic syndrome (MDS) IVD, probe
  • Acute myeloid leukaemia (AML) genetic mutation IVD, probe
Del(7q) Deletion FISH Probe Kit
CYTOCELL LIMITED
USA-LPH025
In Commercial Distribution

  • 05055844901568 ()
USA-LPH025

  • Myelodysplastic syndrome (MDS) IVD, probe
  • Acute myeloid leukaemia (AML) genetic mutation IVD, probe
Del(5q) Deletion FISH Probe Kit
CYTOCELL LIMITED
USA-LPH024
In Commercial Distribution

  • 05055844901551 ()
USA-LPH024

  • Myelodysplastic syndrome (MDS) IVD, probe
  • Acute myeloid leukaemia (AML) genetic mutation IVD, probe
EYE Q STERILE LABELS
CENTURION MEDICAL PRODUCTS CORPORATION
STL3024
In Commercial Distribution

  • 10653160230205 ()
  • 00653160230208 ()
STL3024

  • Procedural medication labelling set
44 9.5X10 1000_CASE Q
STERIMED INC.
1010449.510
In Commercial Distribution

  • 00815588021169 ()
  • 00815588021152 ()
1010449.510

  • Sterilization packaging, single-use
44 10X10 1000_CASE Q
STERIMED INC.
1010441010
In Commercial Distribution

  • 00815588021084 ()
  • 00815588021022 ()
1010441010

  • Sterilization packaging, single-use
SonixSP Q+Ultrasound System
ANALOGIC CORPORATION
22.000.000-02
Not in Commercial Distribution

  • 08294362200020 ()


  • General-purpose ultrasound imaging system
SonixOP Q+ Ultrasound System
ANALOGIC CORPORATION
21.000.000-02
Not in Commercial Distribution

  • 08294362100023 ()


  • General-purpose ultrasound imaging system
SonixMDP Q+ Ultrasound System
ANALOGIC CORPORATION
20.000.000-02
Not in Commercial Distribution

  • 08294362000026 ()


  • General-purpose ultrasound imaging system
SonixTOUCH Q+ Ultrasound System
ANALOGIC CORPORATION
18.000.000-02
Not in Commercial Distribution

  • 08294361800023 ()


  • General-purpose ultrasound imaging system
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