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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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Head Aligner
UNIFIED SPINE, LLC
504129
In Commercial Distribution

  • M9935041290 ()

  • Head Aligner


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Head Aligner
UNIFIED SPINE, LLC
504128
In Commercial Distribution

  • M9935041280 ()

  • Head Aligner


  • Orthopaedic surgical procedure kit, non-medicated, reusable
10-12mm Dilator
UNIFIED SPINE, LLC
504126
In Commercial Distribution

  • M9935041260 ()

  • 10-12mm Dilator


  • Orthopaedic surgical procedure kit, non-medicated, reusable
8-10mm Dilator
UNIFIED SPINE, LLC
504125
In Commercial Distribution

  • M9935041250 ()

  • 8-10mm Dilator


  • Orthopaedic surgical procedure kit, non-medicated, reusable
6-8mm Dilator
UNIFIED SPINE, LLC
504124
In Commercial Distribution

  • M9935041240 ()

  • 8-10mm Dilator


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Driver Sleeve
UNIFIED SPINE, LLC
504120
In Commercial Distribution

  • M9935041200 ()

  • Driver Sleeve


  • Orthopaedic implantation sleeve, reusable
Mechanical Reducer
UNIFIED SPINE, LLC
504114
In Commercial Distribution

  • M9935041140 ()

  • Mechanical Reducer


  • Orthopaedic rod reducer
Mechanical Reducerr
UNIFIED SPINE, LLC
504112
In Commercial Distribution

  • M9935041120 ()

  • Mechanical Reducer


  • Orthopaedic rod reducer
Ratchet QC Driver for Poly-Axial Screw Inst
UNIFIED SPINE, LLC
504110
In Commercial Distribution

  • M9935041100 ()

  • Ratchet QC Driver for Poly-Axial Screw Inst


  • Surgical instrument handle, non-torque-limiting
Mechanical Rod Reducer
UNIFIED SPINE, LLC
504108
In Commercial Distribution

  • M9935041080 ()

  • Mechanical Rod Reducer


  • Orthopaedic rod reducer
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