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
MySpine Cerv Omega Drill Solid Ø2.9x12 stop long
Medacta International SA
03.75.10.0831
In Commercial Distribution

  • 07630542703829 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
MySpine Cerv Omega Drill Solid Ø2.4x20 stop long
Medacta International SA
03.75.10.0829
In Commercial Distribution

  • 07630542703805 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
MySpine Cerv Omega Drill Solid Ø2.4x12 stop long
Medacta International SA
03.75.10.0827
In Commercial Distribution

  • 07630542703782 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
MySpine Cerv Omega Drill Solid Ø2.9x25 stop long
Medacta International SA
03.75.10.0834
In Commercial Distribution

  • 07630542703850 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
MySpine Cerv Omega Drill Solid Ø2.9x14 stop long
Medacta International SA
03.75.10.0832
In Commercial Distribution

  • 07630542703836 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
MySpine Cerv Omega Drill Solid Ø2.4x25 stop long
Medacta International SA
03.75.10.0830
In Commercial Distribution

  • 07630542703812 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
MySpine Cerv Omega Drill Solid Ø2.4x14 stop long
Medacta International SA
03.75.10.0828
In Commercial Distribution

  • 07630542703799 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
MySpine Cerv Omega Drill Solid Ø2.9x25 stop short
Medacta International SA
03.75.10.0826
In Commercial Distribution

  • 07630542703775 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
MySpine Cerv Omega Drill Solid Ø2.9x20 stop short
Medacta International SA
03.75.10.0825
In Commercial Distribution

  • 07630542703768 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
MySpine Cerv Omega Drill Solid Ø2.9x14 stop short
Medacta International SA
03.75.10.0824
In Commercial Distribution

  • 07630542703751 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
MySpine Cerv Omega Drill Solid Ø2.9x12 stop short
Medacta International SA
03.75.10.0823
In Commercial Distribution

  • 07630542703744 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
MySpine Cerv Omega Drill Solid Ø2.4x25 stop short
Medacta International SA
03.75.10.0822
In Commercial Distribution

  • 07630542703737 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
MySpine Cerv Omega Drill Solid Ø2.4x20 stop short
Medacta International SA
03.75.10.0821
In Commercial Distribution

  • 07630542703720 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
MySpine Cerv Omega Drill Solid Ø2.4x14 stop short
Medacta International SA
03.75.10.0820
In Commercial Distribution

  • 07630542703713 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
MySpine Cerv Omega Drill Solid Ø2.4x12 stop short
Medacta International SA
03.75.10.0819
In Commercial Distribution

  • 07630542703706 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
MySpine Cerv Omega Drill Solid Ø2.9x16 stop long
Medacta International SA
03.75.10.0838
In Commercial Distribution

  • 07630542714283 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
MySpine Cerv Omega Drill Solid Ø2.4x16 stop long
Medacta International SA
03.75.10.0837
In Commercial Distribution

  • 07630542714276 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
MySpine Cerv Omega Drill Solid Ø2.9x16 stop short
Medacta International SA
03.75.10.0836
In Commercial Distribution

  • 07630542714269 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
MySpine Cerv Omega Drill Solid Ø2.4x16 stop short
Medacta International SA
03.75.10.0835
In Commercial Distribution

  • 07630542714252 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
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 with Full Stimulation Source
In Commercial Distribution

  • 27290016450891 ()
750-02J016-00

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

  • 27290016450877 ()
750-02A016-00

  • Depth electrode
PLT BL2
TOKUYAMA DENTAL CORPORATION
10751
In Commercial Distribution

  • 04548190107513 ()
  • 94548190107516 ()


  • Dental composite resin
PLT BL1
TOKUYAMA DENTAL CORPORATION
10750
In Commercial Distribution

  • 04548190107506 ()
  • 94548190107509 ()


  • Dental composite resin
PLT DA3
TOKUYAMA DENTAL CORPORATION
10749
In Commercial Distribution

  • 04548190107490 ()
  • 94548190107493 ()


  • Dental composite resin
PLT DA2
TOKUYAMA DENTAL CORPORATION
10748
In Commercial Distribution

  • 04548190107483 ()
  • 94548190107486 ()


  • Dental composite resin
PLT DA1
TOKUYAMA DENTAL CORPORATION
10747
In Commercial Distribution

  • 04548190107476 ()
  • 94548190107479 ()


  • Dental composite resin
PLT MW
TOKUYAMA DENTAL CORPORATION
10746
In Commercial Distribution

  • 04548190107469 ()
  • 94548190107462 ()


  • Dental composite resin
PLT Trans
TOKUYAMA DENTAL CORPORATION
10745
In Commercial Distribution

  • 04548190107452 ()
  • 94548190107455 ()


  • Dental composite resin
PLT EB1
TOKUYAMA DENTAL CORPORATION
10744
In Commercial Distribution

  • 04548190107445 ()
  • 94548190107448 ()


  • Dental composite resin
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