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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Orthorama® sectional arches without Omega loop
DENTAURUM GmbH & Co.KG
728-217-00
In Commercial Distribution

  • J011728217000 ()
  • J011728217001 ()


  • Orthodontic archwire
Orthorama® sectional arches with Omega loop
DENTAURUM GmbH & Co.KG
728-216-00
In Commercial Distribution

  • J011728216000 ()
  • J011728216001 ()


  • Orthodontic archwire
HEINE OMEGA 500 BINO OPHTHALMOSCOPE TRAINING MIRROR
SONTEC INSTRUMENTS, INC.
C-000.33.209
In Commercial Distribution

  • 00192896071513 ()
C-000.33.209

  • General/plastic surgery mirror
HEINE - OMEGA 180 WITH EN15 AND TRANSFORMER
SONTEC INSTRUMENTS, INC.
C-004.33.226
Not in Commercial Distribution

  • 00192896009486 ()
C-004.33.226

  • Loupe
Omega Drill Ø2.7mm STD-conn Removable locking handle
Medacta International SA
03.51.10.0792
In Commercial Distribution

  • 07630971289826 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Omega Drill Ø2.7mm AO-conn Removable locking handle
Medacta International SA
03.51.10.0790
In Commercial Distribution

  • 07630971289802 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Ø3.2 Guide wire 450mm - Omega Drill bit
Medacta International SA
03.65.10.0176
In Commercial Distribution

  • 07630345779793 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Ø3.2 Guide wire 305mm - Omega Drill bit
Medacta International SA
03.65.10.0175
In Commercial Distribution

  • 07630345779786 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
MySpine Ø2 Omega drill, AO conn - 10mm
Medacta International SA
03.51.10.0746
In Commercial Distribution

  • 07630542726217 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
MySpine Ø2 Omega drill, AO conn - 15mm
Medacta International SA
03.51.10.0745
In Commercial Distribution

  • 07630542726200 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
MySpine Ø2 Omega drill, AO conn - 20mm
Medacta International SA
03.51.10.0744
In Commercial Distribution

  • 07630542726194 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Earloop Mask Omega Pleat ASTM Level 3 Blue
HENRY SCHEIN, INC.
5703289
In Commercial Distribution

  • 00304040168585 ()
  • 10304040168582 ()
5703289

  • Surgical/medical face mask, non-antimicrobial, single-use
5.5MM ALPHAVENT AND 4.75MM HARD BONE OMEGA DRILL
STRYKER CORPORATION
3910947203
In Commercial Distribution

  • 07613327550092 ()
3910-947-203

  • Fluted surgical drill bit, reusable
Zephyr IR Bridge for GE OMEGA Biplane Table
Diacor, Inc.
ZXL-ATB-15
In Commercial Distribution

  • B237ZXLATB150 ()


  • Radiological whole-body positioner
OMEGA XP® AXIAL INSERTER INNER SHAFT - SHORT
SPINAL ELEMENTS, INC.
11402-265
In Commercial Distribution

  • 00840606163255 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
GE OMEGA IV TABLE PAD 1" SUPER-SUPPORT FOAM
AADCO MEDICAL, INC.
TP-981C
In Commercial Distribution

  • 00840348513028 ()
TP-981C

  • Freestanding patient positioner, reusable
GE OMEGA IV TABLE PAD 2" LO-SORB FOAM
AADCO MEDICAL, INC.
TP-981
In Commercial Distribution

  • 00840348513011 ()
TP-981

  • Freestanding patient positioner, reusable
HEINE - OMEGA 500 UNPLUGGED WITH HC50 L HEADBAND
SONTEC INSTRUMENTS, INC.
C-004.33.503
Not in Commercial Distribution

  • 00192896009493 ()
C-004.33.503

  • Loupe
532nm Heine Omega Indirect Ophthalmoscope with integrated adaptor
QUANTEL MEDICAL
IOH810532
In Commercial Distribution

  • 03700542625224 ()


  • Indirect binocular laser ophthalmoscope
MySpine Cerv Omega Drill Solid Ø2.9x20 stop long
Medacta International SA
03.75.10.0833
In Commercial Distribution

  • 07630542703843 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
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