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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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ORTHOGNATHIC, SURGICAL PLANNING KIT W/ 3D PRINTED TITANIUM PLATES AND TITANIUM HYBRID GUIDES
Medcad
MC-KTP000-H
In Commercial Distribution

  • 00864582000274 ()
MC-KTP000-H

  • Dental milling system, CAD/CAM, laboratory
  • Custom-made organ/bone anatomy model/surgical guide kit
  • Craniofacial fixation plate, non-bioabsorbable, non-customized
AdvantageRib X-Driver, AO Quick-Connect
SIG MEDICAL CORP.
323.0075
In Commercial Distribution

  • 00854865007403 ()
323.0075

  • Surgical screwdriver, reusable
Slap Hammer
DECIMA SPINE, INC.
6120
In Commercial Distribution

  • 00857360007107 ()
6120

  • Surgical mallet
REMOVAL DRIVER
DECIMA SPINE, INC.
6096
In Commercial Distribution

  • 00857360007077 ()
6096

  • Surgical screwdriver, reusable
Driver
DECIMA SPINE, INC.
6094
In Commercial Distribution

  • 00857360007053 ()
6094

  • Surgical screwdriver, reusable
No Description
Moximed, Inc.
1-4039
In Commercial Distribution

  • 00856047005917 ()


  • Orthopaedic surgical procedure kit, non-medicated, single-use
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
The Ferrule package contains 1 Ferrule, 1 Ferrule Clamp and 1 Torque Driver.
Neuropace, Inc.
F-01-K
In Commercial Distribution

  • 00855547005373 ()


  • Brain-responsive electrical stimulation system
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