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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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DRIVER EX0615015 BONESCREW T-25
MEDTRONIC SOFAMOR DANEK, INC.
EX0615015
In Commercial Distribution

  • 00643169652224 ()


  • Surgical screwdriver, reusable
DRIVER 5482304 7/32 BREAKOFF DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
5482304
In Commercial Distribution

  • 00643169641617 ()


  • Orthopaedic implant driver
Flexible Screwdriver Shaft (3.5mm Hex)
X-BOLT ORTHOPEDICS INC.
XNI-023
In Commercial Distribution

  • 05397283000212 ()


  • Surgical screwdriver, reusable
Short Screwdriver Shaft (3.5mm Hex)
X-BOLT ORTHOPEDICS INC.
XNI-022
In Commercial Distribution

  • 05397283000205 ()


  • Surgical screwdriver, reusable
Long Screwdriver Shaft (3.5mm Hex)
X-BOLT ORTHOPEDICS INC.
XNI-021
In Commercial Distribution

  • 05397283000199 ()


  • Surgical screwdriver, reusable
T20 Torx screwdriver (4.5Nm Torque Limit)
X-BOLT ORTHOPEDICS INC.
XNI-020
In Commercial Distribution

  • 05397283000182 ()


  • Surgical screwdriver, reusable
T10 Torque Driver
SUBCHONDRAL SOLUTIONS, INC.
10-4010
In Commercial Distribution

  • 00850017962422 ()
10-4010

  • Orthopaedic bone screw, non-bioabsorbable, sterile
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
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
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
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