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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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Ball Hex Driver 6mm, Teardrop
Orthalign, Inc.
403211
In Commercial Distribution

  • 00858704006756 ()
403211

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Hex Driver - 3.5mm, Hudson Connector
Orthalign, Inc.
403106
In Commercial Distribution

  • 00858704006619 ()
403106

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Hex Driver - 3.5mm, Teardrop
Orthalign, Inc.
403105
In Commercial Distribution

  • 00858704006602 ()
403105

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Pin Driver, Tri-Flat, 3.2mm
Orthalign, Inc.
403189
In Commercial Distribution

  • 00858704006435 ()
403189

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Pin Driver
Orthalign, Inc.
402067
In Commercial Distribution

  • 00858704006428 ()
402067

  • Orthopaedic surgical procedure kit, non-medicated, reusable
2.5mm Ball Driver
Orthalign, Inc.
402048
In Commercial Distribution

  • 00858704006374 ()
402048

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Ziptek large stainless steel driver/handle assembly reusable medical grade stainless steel ofr use with large 5.0mm screws and biocomposite plugs and as ZipE capture/button pusher
ZIPTEK LLC
B56-793-S_D
In Commercial Distribution

  • 00858816006101 ()
01

  • Surgical instrument handle, non-torque-limiting
Ziptek small driver/handle assembly medical grade stainless steel for 4.5mm screw insertion and for pushing capture/button
ZIPTEK LLC
B56-635-S_D
In Commercial Distribution

  • 00858816006088 ()
88

  • Surgical instrument handle, non-torque-limiting
Maxilla Cutting Guide Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860012759460 ()
GCMAXTI

  • Custom-made orthopaedic/craniofacial surgical guide
Mandible Cutting Guide Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution

  • 00860012759453 ()
GCMANTI

  • Custom-made orthopaedic/craniofacial surgical guide
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