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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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
GEL MARK ULTRA™ Breast Tissue Marker, 7 Ga EnCor, SS "Omega"
SENORX, INC.
GMUEC7GSS
In Commercial Distribution

  • 10801741031868 ()
  • 00801741031861 ()

  • Needle Gauge: 7 Gauge
GMUEC7GSS

  • Radiological image marker, implantable
GEL MARK ULTRA™ Breast Tissue Marker, 11 Ga Mammotome, SS "Omega"
SENORX, INC.
MK2011
Not in Commercial Distribution

  • 10801741031882 ()
  • 00801741031885 ()

  • Needle Gauge: 11 Gauge
MK2011

  • Radiological image marker, implantable
GEL MARK ULTRA™ Breast Tissue Marker, 10 Ga EnCor, SS "Omega"
SENORX, INC.
GMUEC10GSS
In Commercial Distribution

  • 10801741031851 ()
  • 00801741031854 ()

  • Needle Gauge: 10 Gauge
GMUEC10GSS

  • Radiological image marker, implantable
Ossicular Prosthesis, total
Heinz Kurz GmbH
1004930
In Commercial Distribution

  • EHKM10049301 ()
1004930

  • Ossicular prosthesis, total
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
insertion tube Array electrode
In Commercial Distribution

  • 07290016450828 ()
  • 17290016450825 ()
366-70ITAR-00

  • Intracerebral cannula, implantable
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Insertion Tube Set 15mm above
In Commercial Distribution

  • 07290016450804 ()
  • 17290016450801 ()
366-66IT07-00

  • Intracerebral cannula, implantable
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Insertion Tube Set 20mm above
In Commercial Distribution

  • 07290016450798 ()
  • 17290016450795 ()
366-66IT05-00

  • Intracerebral cannula, implantable
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Insertion Tube Set 40mm above
In Commercial Distribution

  • 07290016450781 ()
  • 17290016450788 ()
366-66IT01-00

  • Intracerebral cannula, implantable
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