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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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Valence Robotic Navigation System - 00190376540146

5.0 mm Awl Tap, Power, Robot
ALPHATEC SPINE, INC.
525-16434-050-RJ
In Commercial Distribution

  • 00190376540146 ()


  • Bone tap, reusable

Valence Robotic Navigation System - 00190376540122

4.5 mm Awl Tap, Power, Robot
ALPHATEC SPINE, INC.
525-16434-045-RJ
In Commercial Distribution

  • 00190376540122 ()


  • Bone tap, reusable

Invictus - 00190376450094

Derotation AR 45 Power Adapter, Jacobs
ALPHATEC SPINE, INC.
16049
In Commercial Distribution

  • 00190376450094 ()


  • Orthopaedic implant-instrument extension adaptor, reusable

DYONICS, ULTRA - 03596010447234

MTO REPLACEMNT POWER CORD ULTRA SHAVER
Smith & Nephew, Inc.
7209071
In Commercial Distribution

  • 03596010447234 ()
7209071

  • Electrical mains power cable

DYONICS - 03596010251961

EP-1 POWER FOOTSWITCH, PEDAL-STYLE, ON/OFF
Smith & Nephew, Inc.
7205396
In Commercial Distribution

  • 03596010251961 ()
7205396

  • Foot-switch, electrical

CARDINAL HEALTH - 10885380097690

NPWT SVED/ Catalyst™ Power Adapter
Cardinal Health 200, LLC
47-9000
Not in Commercial Distribution

  • 10885380097690 ()
47-9000

  • Negative-pressure wound therapy system pump, electric

Kendall SCD - 10884521129634

KENDALL SCD 700 CONTROLLER US POWER
Cardinal Health, Inc.
U29525
In Commercial Distribution

  • 10884521129634 ()
U29525

  • Sequential venous compression system inflator

LnK Spinal Instrument System - 08800061399493

Reduction Polyaxial Screw driver Long Power
L&K BIOMED CO. ,LTD.
LS05-CM39
In Commercial Distribution

  • 08800061399493 ()
LS05-CM39

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Kinetic-SL Dynamic Anterior Cervical Plate System - 00190837037406

NEO-UL Hexalobe T10 Screwdriver, AO Power
Life Spine, Inc.
2016-0219
In Commercial Distribution

  • 00190837037406 ()
2016-0219

  • Spinal fixation plate, non-bioabsorbable

Kinetic-SL Dynamic Anterior Cervical Plate System - 00190837037390

ACPS Hexalobe T10 Screwdriver, AO Power
Life Spine, Inc.
2016-0218
In Commercial Distribution

  • 00190837037390 ()
2016-0218

  • Spinal fixation plate, non-bioabsorbable
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