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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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, 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, 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
5.0 MM X 2.35 MM X 63.0 MM PILOT POINT SWANSON STAINLESS STEEL BUR, 7 FLUTE
Omega Surgical Instruments Inc
H-145
In Commercial Distribution

  • 00817438021336 ()


  • Orthopaedic bur, single-use
4.0 MM X 2.35 MM X 62.00 MM PILOT POINT SWANSON STAINLESS STEEL BUR, 6 FLUTE
Omega Surgical Instruments Inc
H-144
In Commercial Distribution

  • 00817438021329 ()


  • Orthopaedic bur, single-use
3.0 MM X 2.35 MM X 62.0 MM PILOT POINT SWANSON STAINLESS STEEL BUR, 5 FLUTE
Omega Surgical Instruments Inc
H-143
In Commercial Distribution

  • 00817438021312 ()


  • Orthopaedic bur, single-use
2.0 MM X 2.35 MM X 55.5 MM PILOT POINT SWANSON STAINLESS STEEL BUR, 4 FLUTE
Omega Surgical Instruments Inc
H-142
In Commercial Distribution

  • 00817438021305 ()


  • Orthopaedic bur, single-use
5.5 MM X 2.35 MM X 48.0 MM OVAL CARBIDE BUR, 10 FLUTE
Omega Surgical Instruments Inc
H-138
In Commercial Distribution

  • 00817438021299 ()


  • Orthopaedic bur, single-use
4.0 MM X 2.35 MM X 48.0 MM ROUND CARBIDE BUR, 8 FLUTE
Omega Surgical Instruments Inc
H-128
In Commercial Distribution

  • 00817438021251 ()


  • Orthopaedic bur, single-use
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