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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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INSTRUMENT 858-959 IG M8 FIXED SCRWDRVER
MEDTRONIC SOFAMOR DANEK, INC.
858-959
In Commercial Distribution

  • 00721902038662 ()


  • Surgical screwdriver, reusable
INSTRUMENT 8361954 TSH 3D VB TH PST SCDR
MEDTRONIC SOFAMOR DANEK, INC.
8361954
In Commercial Distribution

  • 00721902034169 ()

  • 3.5mm


  • Orthopaedic implant driver
INSTRUMENT 8361953 TSRH 3D VBR THR NT DR
MEDTRONIC SOFAMOR DANEK, INC.
8361953
In Commercial Distribution

  • 00721902033551 ()

  • 7.5mm


  • Surgical screwdriver, reusable
Headless Compression System 2.0mm Hex Driver Shaft Cannulated
Osteocentric Technologies, Inc.
EX01-0033
In Commercial Distribution

  • 00850015496394 ()
EX01-0033

  • Surgical screwdriver, reusable
Headless Compression System 1.5mm Hex Driver Shaft Cannulated
Osteocentric Technologies, Inc.
EX01-0032
In Commercial Distribution

  • 00850015496387 ()
EX01-0032

  • Surgical screwdriver, reusable
The Computerized Dynamic Posturography (CDP ) system is a clinical balance assessment device that collects and analyzes force and moment data from a balance plate. The balance plate is seated in a dynamic chassis that can move in both translational and rotational directions, under control of the Balance Advantage (BA) software program. The BA software contains both assessment and training modules that can be used during each session. Assessments have set run-times during which they collect data after the “Start” button is pressed, while trainings have customizable run-times varying from 1 minute to 15 minutes. The system is intended to be used by trained clinicians in a hospital or clinical (physical therapy or ENT) environment who operate the software and ensure the safety of the patient. The patient being assessed on the system is placed in a harness. There are three different harness sizes with varying weight limits that can be purchase with the system; standard harness supports up to 300lbs, pediatric is up to 100lbs, and the bariatric supports up to 450lbs. The mechanical components of the system are designed to support up to 500lb patients.
BERTEC CORPORATION
97P-0036
In Commercial Distribution

  • 00850017250079 ()


  • Posturography system platform
DRIVER EX0616017 HEX RETAINING
MEDTRONIC SOFAMOR DANEK, INC.
EX0616017
In Commercial Distribution

  • 00643169834422 ()


  • Surgical screwdriver, reusable
DRIVER EX0616012 SHORTEN T8-T10
MEDTRONIC SOFAMOR DANEK, INC.
EX0616012
In Commercial Distribution

  • 00643169800106 ()


  • Surgical screwdriver, reusable
DRIVER X0416007 NUT 4.75 REDUCER
MEDTRONIC SOFAMOR DANEK, INC.
X0416007
In Commercial Distribution

  • 00643169800045 ()


  • Orthopaedic rod reducer
REDUCER X0416006 4.75
MEDTRONIC SOFAMOR DANEK, INC.
X0416006
In Commercial Distribution

  • 00643169800038 ()


  • Surgical screwdriver, reusable
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