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 28MM X 10MM 0° LUMBAR EXPANDABLE INTERBODY
SPINAL ELEMENTS
72-00-092810-00
In Commercial Distribution

  • 00840916124618 ()


  • Metallic spinal interbody fusion cage
OMEGA XP™ 9MM X 28MM X 8MM 0° LUMBAR EXPANDABLE INTERBODY
SPINAL ELEMENTS
72-00-092808-00
In Commercial Distribution

  • 00840916124601 ()


  • Metallic spinal interbody fusion cage
ARTICULATING RAKE W/ RATCHET
SPINAL ELEMENTS, INC.
SP-0539
In Commercial Distribution

  • 00840916148577 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
Heine Optotechnik GmbH & Co. KG
000
In Commercial Distribution

  • 04053755198382 ()
C-008.33.600

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

  • 04053755181704 ()
C-004.33.563

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

  • 04053755153541 ()
C-004.33.507

  • Indirect binocular ophthalmoscope
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega EMG- recording with Full Stimulation Source
In Commercial Distribution

  • 27290016450938 ()
750-02J013-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega ECoG Recording Kit
In Commercial Distribution

  • 27290016450877 ()
750-02A016-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Neuro Omega ECoG- Recording with Full Stimulation Source
In Commercial Distribution

  • 27290016450891 ()
750-02J016-00

  • Depth electrode
OMEGALIF DISC CUTTER INNER SHAFT
SPINAL ELEMENTS, INC.
11421-000
In Commercial Distribution

  • 00840606174787 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
313/A2-010 Head End Shield - Panneau Tablle Omega 5
KENEX (ELECTRO-MEDICAL) LIMITED
313/A2-010
In Commercial Distribution

  • 05055449407175 ()
313/A2-010

  • Radiation shielding curtain
OMEGA XP™ 9MM X 34MM X 8MM 0°
SPINAL ELEMENTS
72-00-093408-00
In Commercial Distribution

  • 00840916133221 ()


  • Metallic spinal interbody fusion cage
OMEGA XP™ 9MM X 28MM X 11MM 11°
SPINAL ELEMENTS
72-00-092811-11
In Commercial Distribution

  • 00840916124687 ()


  • Metallic spinal interbody fusion cage
577nm Heine Omega 500 Indirect Ophthalmoscope with integrated adaptor
QUANTEL MEDICAL
IOH577
In Commercial Distribution

  • 03700542625392 ()


  • Indirect binocular laser ophthalmoscope
GE OMEGA III TABLE PAD 1 1/2" LAMIFOAM
AADCO MEDICAL, INC.
TP-982L
In Commercial Distribution

  • 00840348513066 ()
TP-982L

  • Freestanding patient positioner, reusable
GE OMEGA III TABLE PAD 1" SUPER SUPPORT FOAM
AADCO MEDICAL, INC.
TP-982C
In Commercial Distribution

  • 00840348513059 ()
TP-982C

  • Freestanding patient positioner, reusable
G.E. OMEGA V TABLE PAD 1" SUPER SUPPORT COATED
AADCO MEDICAL, INC.
TP-980C
In Commercial Distribution

  • 00840348512991 ()
TP-980C

  • Freestanding patient positioner, reusable
OMEGA XP™ 9MM X 34MM X 11MM 8° C
SPINAL ELEMENTS
72-01-093411-08
In Commercial Distribution

  • 00840916133269 ()


  • Metallic spinal interbody fusion cage
OMEGA XP™ 9MM X 34MM X 11MM 3° C
SPINAL ELEMENTS
72-01-093411-03
In Commercial Distribution

  • 00840916133252 ()


  • Metallic spinal interbody fusion cage
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
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
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