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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577nm Heine Omega 500 Indirect Ophthalmoscope with integrated adaptor
QUANTEL MEDICAL
IOH577
In Commercial Distribution

  • 03700542625392 ()


  • Indirect binocular laser ophthalmoscope
SENOMARK® Breast Tissue Marker, 12 Ga EnCor, SS "Omega"
SENORX, INC.
SMEC12GSS
In Commercial Distribution

  • 10801741031929 ()
  • 00801741031922 ()

  • Needle Gauge: 12 Gauge
SMEC12GSS

  • Radiological image marker, implantable
GEL MARK ULTRACOR Breast Tissue Marker, 14 Gauge, SS "Omega"
SENORX, INC.
GMUTC005SS
In Commercial Distribution

  • 10801741031899 ()
  • 00801741031892 ()

  • Needle Gauge: 14 Gauge
  • Needle Length, 10 Centimeter
GMUTC005SS

  • Radiological image marker, implantable
STARCHMARK® Breast Tissue Marker, 11 Ga Mammotome, SS "Omega"
SENORX, INC.
STMKMT11GSS
Not in Commercial Distribution

  • 10801741032186 ()
  • 00801741032189 ()

  • Needle Gauge: 11 Gauge
STMKMT11GSS

  • Radiological image marker, implantable
STARCHMARK® Breast Tissue Marker, 10 Ga EnCor, SS "Omega"
SENORX, INC.
STMKEC10GSS
Not in Commercial Distribution

  • 10801741032162 ()
  • 00801741032165 ()

  • Needle Gauge: 10 Gauge
STMKEC10GSS

  • Radiological image marker, implantable
instrument Rosa 3.0 instrument Rosa 3.1 Alpha Omega microdrive holder
MEDTECH
ROSA-128E
In Commercial Distribution

  • 03760244031181 ()
ROSAS00319

  • Multi-purpose stereotactic surgery system
  • Neurological stereotactic surgery system
OMEGA XP™ 9MM X 34MM X 11MM 8° C
SPINAL ELEMENTS
72-01-093411-08
In Commercial Distribution

  • 00840916133269 ()


  • Metallic spinal interbody fusion cage
OMEGA XP™ 9MM X 34MM X 11MM 3° C
SPINAL ELEMENTS
72-01-093411-03
In Commercial Distribution

  • 00840916133252 ()


  • Metallic spinal interbody fusion cage
OMEGA XP™ 9MM X 34MM X 10MM 3° C
SPINAL ELEMENTS
72-01-093410-03
In Commercial Distribution

  • 00840916133245 ()


  • Metallic spinal interbody fusion cage
OMEGA XP™ 9MM X 34MM X 9MM 3° C
SPINAL ELEMENTS
72-01-093409-03
In Commercial Distribution

  • 00840916133238 ()


  • Metallic spinal interbody fusion cage
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