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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, 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 Explant Kit package contains 2 Lead Caps and 1 Torque Driver.
Neuropace, Inc.
EX-01-K
In Commercial Distribution

  • 00855547005410 ()


  • Brain-responsive electrical stimulation system
The Connector Cover package contains 1 Connector Cover, 2 Connector Plugs, 1 Lead Strain Relief and 1 Torque Driver.
Neuropace, Inc.
CC-01-K
In Commercial Distribution

  • 00855547005397 ()


  • Brain-responsive electrical stimulation system
The Craniectomy Template package contains 1 Craniectomy Template, 1 Lead Strain Relief and 1 Torque Driver.
Neuropace, Inc.
CT-01-K
In Commercial Distribution

  • 00855547005380 ()


  • Brain-responsive electrical stimulation system
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