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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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
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
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
GE OMEGA 1V TABLE PAD 1 1/2" LAMI FOAM
AADCO MEDICAL, INC.
TP-981L
In Commercial Distribution

  • 00840348513035 ()
TP-981L

  • Freestanding patient positioner, reusable
GE OMEGA V TABLE PAD 1 1/2" LAMIFOAM COVERED
AADCO MEDICAL, INC.
TP-980L
In Commercial Distribution

  • 00840348513004 ()
TP-980L

  • Freestanding patient positioner, reusable
GE OMEGA V TABLE PAD 2" LO-SORB W/BLACK NYLON
AADCO MEDICAL, INC.
TP-980
In Commercial Distribution

  • 00840348512984 ()
TP-980

  • Freestanding patient positioner, reusable
No Description
Shanghai United Imaging Healthcare Co., Ltd.
uMR Omega
In Commercial Distribution

  • 06971576830114 ()


  • Full-body MRI system, superconducting magnet
3M™ Unitek™ Prestige Omega Loop Forming Pliers, 900-707, 1/Ea
3M UNITEK CORPORATION
900-708
In Commercial Distribution

  • 00652221110992 ()
900-708

  • Orthodontic pliers
OTP (Over-travel protection) solution kit for GE Omega or IQ Tilt Tables
Diacor, Inc.
ZXL-AOT-12
In Commercial Distribution

  • B237ZXLAOT120 ()


  • Radiological whole-body positioner
  • Patient lifting system stretcher
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