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 9MM 3° C
SPINAL ELEMENTS
72-01-093409-03
In Commercial Distribution

  • 00840916133238 ()


  • Metallic spinal interbody fusion cage
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
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
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
In Commercial Distribution

  • 03760244031365 ()
ROSAS00344

  • Multi-purpose stereotactic surgery system
  • Neurological stereotactic surgery system
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
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
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-172-720
In Commercial Distribution

  • 09348215076566 ()


  • Orthopaedic implant driver
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
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
No Description
Heine Optotechnik GmbH & Co. KG
000
In Commercial Distribution

  • 04053755153695 ()
C-008.33.502

  • Indirect binocular ophthalmoscope
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega HS
In Commercial Distribution

  • 07290014954922 ()
750-000070-00

  • Neurological stereotactic surgery system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega HS
In Commercial Distribution

  • 07290014954915 ()
750-000020-00

  • Neurological stereotactic surgery system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega system
In Commercial Distribution

  • 07290114061506 ()
NOM-000000-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega with Neuro Omega Drive Headstage
In Commercial Distribution

  • 27290114064525 ()
NOW-020021-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega with Neuro Omega Drive Headstage
In Commercial Distribution

  • 27290114063856 ()
NOW-020021-00

  • Depth electrode
ERBE NESSY® Omega Plate USA (85+23)cm² , with cable 3 m
Erbe Elektromedizin GmbH
20193-084
In Commercial Distribution

  • 04050147015593 ()
  • 04050147005235 ()
  • 04050147017481 ()

  • Area/Surface Area: 85.000 Square centimeter
20193-084

  • Electrosurgical return electrode, single-use
DELTA-9-THC 8 NG/ML
UTAK LABORATORIES, INC.
DELTA 9 OMEGA
In Commercial Distribution

  • B800DELTA9THC8NGML5 ()
  • B800DELTA9THC8NGML0 ()

  • Total Volume: 1 Milliliter
DELTA 9 OMEGA

  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
UTAK LABORATORIES, INC.
DELTA 9 OMEGA
In Commercial Distribution

  • B800DELTA9OMEGA5 ()
  • B800DELTA9OMEGA0 ()

  • Total Volume: 1 Milliliter
DELTA 9 OMEGA

  • Multiple-type clinical chemistry analyte profile IVD, control
3M™ Unitek™ Prestige Series Omega Loop Forming Pliers Replacement Tip, 900-708, 1/Ea
3M UNITEK CORPORATION
900-709
In Commercial Distribution

  • 00652221111005 ()
900-709

  • Orthodontic pliers
Digital Medical Image Processor
OMEGA MEDICAL IMAGING, LLC
IPS-100
In Commercial Distribution

  • 00853901007032 ()


  • X-ray system computer, diagnostic, general-purpose
Interventional Imaging System consisting of a C-Arm, Patient Table, High Voltage Generator, X-Ray Tube, Flat Panel Detector and Image Processor.
OMEGA MEDICAL IMAGING, LLC
Soteria.AI
In Commercial Distribution

  • 00853901007025 ()


  • Stationary angiographic x-ray system, digital
CS-series-FP is a Complete System Flat Panel fluoroscopic Imaging System consisting of a patient table, C-arm positioner, X-ray tube, X-ray generator, Flat Panel Detector and Image Processor. The system is configurable with selectable components i.e. tubes, generators, tables, c-arms and flat panel detectors per customer requirements.
OMEGA MEDICAL IMAGING, LLC
CS-series-FP
In Commercial Distribution

  • 00853901007018 ()


  • Stationary angiographic x-ray system, digital
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
2.4 MM X 2.35 MM X 51.0 MM ROUND CARBIDE BUR, 6 FLUTE
Omega Surgical Instruments Inc
H-125
In Commercial Distribution

  • 00817438021237 ()


  • Orthopaedic bur, single-use
2.0 MM X 2.35 MM X 51.0 MM ROUND CARBIDE BUR, 6 FLUTE
Omega Surgical Instruments Inc
H-124
In Commercial Distribution

  • 00817438021220 ()


  • Orthopaedic bur, single-use
1.5 MM X 2.35 MM X 51.0 MM ROUND CARBIDE BUR, 6 FLUTE
Omega Surgical Instruments Inc
H-122
In Commercial Distribution

  • 00817438021213 ()


  • Orthopaedic bur, single-use
1.0 MM X 2.35 MM X 51.0 MM ROUND CARBIDE BUR, 6 FLUTE
Omega Surgical Instruments Inc
H-120
In Commercial Distribution

  • 00817438021206 ()


  • Orthopaedic bur, single-use
2.0 MM X 2.35 MM X 57.0 MM TAPERED CARBIDE BUR, 6 FLUTE
Omega Surgical Instruments Inc
H-114
In Commercial Distribution

  • 00817438021190 ()


  • Orthopaedic bur, single-use
1.5 MM X 2.35 MM X 67.0 MM SERRATED LINDEMANN SS BUR, 4 FLUTE
Omega Surgical Instruments Inc
H-112
In Commercial Distribution

  • 00817438021183 ()


  • Orthopaedic bur, single-use
2.1 MM X 2.35 MM X 51.0 MM TAPERED SIDE CUTTING CARBIDE BUR, 6 FLUTE
Omega Surgical Instruments Inc
H-106
In Commercial Distribution

  • 00817438021176 ()


  • Orthopaedic bur, single-use
1.5 MM X 2.35 MM X 51.0 MM STRAIGHT SIDE CUTTING CARBIDE BUR, 6 FLUTE
Omega Surgical Instruments Inc
H-104
In Commercial Distribution

  • 00817438021169 ()


  • Orthopaedic bur, single-use
1.0 MM X 2.35 MM X 51.0 MM STRAIGHT SIDE CUTTING CARBIDE BUR, 6 FLUTE
Omega Surgical Instruments Inc
H-101
In Commercial Distribution

  • 00817438021145 ()


  • Orthopaedic bur, single-use
90.0 MM X 12.7 MM X 1.27 MM DIAMAX DIAMOND CUT SAGITTAL BLADE
Omega Surgical Instruments Inc
DXS-210
In Commercial Distribution

  • 00817438021138 ()


  • Surgical saw blade, sagittal, single-use
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