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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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Apex - 05391529581855

Long Removal and Insertion Hex (5mm)
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1136
In Commercial Distribution

  • 05391529581855 ()
INS-1136

  • Surgical screwdriver, reusable

Apex - 05391529581640

Flexible IM Reamer Shaft Extension 150mm
ORTHOXEL DESIGNATED ACTIVITY COMPANY
INS-1135
In Commercial Distribution

  • 05391529581640 ()

  • 150 mm
INS-1135

  • Medullary canal orthopaedic reamer shaft

S-Core™ - 00850017962422

T10 Torque Driver
SUBCHONDRAL SOLUTIONS, INC.
10-4010
In Commercial Distribution

  • 00850017962422 ()
10-4010

  • Orthopaedic bone screw, non-bioabsorbable, sterile

Balance Advantage Computerized Dynamic Posturography System - 00850017250079

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

Amplion Care Assurance - 00850016398024

Alert Display Driver (ADD) - Configuration 2 (curved)
AMPLION CLINICAL COMMUNICATIONS, INC.
D-ADD-X-2
Not in Commercial Distribution

  • 00850016398024 ()
D-ADD-X-2

  • Nurse call system

Amplion Care Assurance - 00850016398017

Alert Display Driver (ADD) - Configuration 1
AMPLION CLINICAL COMMUNICATIONS, INC.
D-ADD-X-1
Not in Commercial Distribution

  • 00850016398017 ()
D-ADD-X-1

  • Nurse call system

Medtronic Reusable Instruments - 00643169585676

DRIVER 5482300 5/16 REVISION DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
5482300
In Commercial Distribution

  • 00643169585676 ()


  • Orthopaedic implant driver

TiMesh® - 00643169582934

TRAY 8004200 BATTERY POWERED DRIVER
MEDTRONIC PS MEDICAL, INC.
8004200
In Commercial Distribution

  • 00643169582934 ()


  • Instrument tray, reusable

RIALTO™ SI FUSION SYSTEM - 00643169571808

DRIVER NAV7426001 SCREW RIALTO
MEDTRONIC SOFAMOR DANEK, INC.
NAV7426001
In Commercial Distribution

  • 00643169571808 ()


  • Surgical screwdriver, reusable

n/a - 00643169601130

DRIVER 4360520 T17 DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
4360520
In Commercial Distribution

  • 00643169601130 ()


  • Surgical screwdriver, reusable
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