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 QUICK KIT PK, F G
Cardinal Health 200, LLC
SBA43QKOIB
In Commercial Distribution

  • 50197106292912 ()
  • 10197106292914 ()
SBA43QKOIB

  • General surgical procedure kit, non-medicated, single-use
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
OMEGA QUICK KIT PK,STRL F/G
Cardinal Health 200, LLC
SBA43QKOI1
In Commercial Distribution

  • 50888439698624 ()
  • 10888439698626 ()
SBA43QKOI1

  • General surgical procedure kit, non-medicated, single-use
Large Round Universal Disc w/ Omega opening
Tz Medical, Inc.
8880-06
In Commercial Distribution

  • 00811331011838 ()
  • 00811331011845 ()


  • Femoral artery compression system, manual, single-use
OMEGA XP® INSERTER INNER SHAFT - SHORT
SPINAL ELEMENTS, INC.
11402-065
In Commercial Distribution

  • 00840606163231 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
OMEGA XP® AXIAL EXPANSION DRIVER - SHORT
SPINAL ELEMENTS, INC.
11418-265
In Commercial Distribution

  • 00840606163293 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
OMEGA XP® AXIAL INSERTER INNER SHAFT
SPINAL ELEMENTS, INC.
11402-295
In Commercial Distribution

  • 00840606163248 ()


  • Orthopaedic prosthesis implantation positioning instrument, 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
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