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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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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
#1 Mead Immunity Mallet
HU-FRIEDY MFG. CO., LLC
MAL1
In Commercial Distribution

  • 10889950014841 ()
MAL1

  • Surgical mallet
Nash/Taylor Crown Remover Hammer
HU-FRIEDY MFG. CO., LLC
CRH
In Commercial Distribution

  • 10889950007003 ()
CRH

  • Surgical mallet
2.0mm x 229mm K-wire
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
WIR2-229
In Commercial Distribution

  • 00856719002237 ()

  • tool/instrument
WIR2-229

  • Manual wire driver
The Burr Hole Cover package contains 1 Burr Hole Cover.
Neuropace, Inc.
8110
In Commercial Distribution

  • 00855547005205 ()

  • Compatible with a 1.3 mm lead. Requires three 1.5 to 1.8 mm bone screws.
  • Outer Diameter: 14 Millimeter


  • Cranial bur hole cover
  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Slap Hammer
DECIMA SPINE, INC.
6120
In Commercial Distribution

  • 00857360007107 ()
6120

  • Surgical mallet
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