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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ALPHA OMEGA MICRODRIVE HOLDER FOR CRW ADAPTOR instrument Rosa 3.0 instrument Rosa 3.1 Alpha Omega microdrive holder for CRW supplied with M5 x 10 wing nut
MEDTECH
ROSA3-196A
Not in Commercial Distribution

  • 03760244031365 ()
ROSAS00344

  • Multi-purpose stereotactic surgery system
  • Neurological stereotactic surgery system
No Description
Shanghai United Imaging Healthcare Co., Ltd.
uMR Omega
In Commercial Distribution

  • 06971576830114 ()


  • Full-body MRI system, superconducting magnet
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
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
CS50 is a Complete System 50 eVIEW Fluoroscopic Imaging system. The Patient table, Positioner, X-Ray tube, Image Receptor and Image processor are configurable with interchangeable components that are customer specific resulting in a unit configuration i.e. CS50-P2-G2-T3-I4-A4.
OMEGA MEDICAL IMAGING, LLC
CS50
In Commercial Distribution

  • 00853901007001 ()


  • Stationary angiographic x-ray system, digital
Ossicular Prosthesis, total
Heinz Kurz GmbH
1004930
In Commercial Distribution

  • EHKM10049301 ()
1004930

  • Ossicular prosthesis, total
No Description
Heine Optotechnik GmbH & Co. KG
000
In Commercial Distribution

  • 04053755198399 ()
C-008.33.601

  • Indirect binocular ophthalmoscope
No Description
Heine Optotechnik GmbH & Co. KG
DV1 CAMERA
In Commercial Distribution

  • 04053755181711 ()
C-008.33.563

  • Indirect binocular ophthalmoscope
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