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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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System 4 Quick Set - 00718175004203

System 4 Quick Set
BIODEX MEDICAL SYSTEMS, INC.
840-000
In Commercial Distribution

  • 00718175004203 ()
840-000

  • Biomechanical function analysis system, force-testing, stationary

ENVISION 3D: LIGHT HANDLE - 00627843746669

No Description
7D Surgical ULC
11-0005
In Commercial Distribution

  • 00627843746669 ()


  • Optical surgical navigation device tracking system workstation, mobile

ENVISION 3D: IMAGE GUIDANCE SYSTEM - 00627843746614

No Description
7D Surgical ULC
10-0001
In Commercial Distribution

  • 00627843746614 ()


  • Optical surgical navigation device tracking system workstation, mobile

7D Surgical System - 00628341520379

No Description
7D Surgical ULC
10-0001
In Commercial Distribution

  • 00628341520379 ()


  • Optical surgical navigation device tracking system workstation, mobile

n.a. - 04048551325971

Navigation-Panel
Karl Storz GmbH & Co. KG
40800021
In Commercial Distribution

  • 04048551325971 ()


  • Optical surgical navigation device tracking system workstation, mobile

Provider Test Kit (PTK) - 10850390007359

A rehabilitation system used to quantify muscle strength and range of motion, as well as quantify compound physical abilities needed for the performance of functional tasks.
BTE TECHNOLOGIES, INC.
1
In Commercial Distribution

  • 10850390007359 ()


  • Biomechanical function analysis system, force-testing, stationary

ER - 10850390007311

No Description
BTE TECHNOLOGIES, INC.
ER
Not in Commercial Distribution

  • 10850390007311 ()


  • Biomechanical function analysis system, force-testing, stationary

Simulator II - 10850390007151

A rehabilitation device for upper extremity strength testing and exercise. The dynamometer offers isometric and concentric isotonic modes, as well as many adapters for isolated joint and compound motions.
BTE TECHNOLOGIES, INC.
Sim II 5
In Commercial Distribution

  • 10850390007151 ()


  • Biomechanical function analysis system, force-testing, stationary

Prism - 10850390007380

A rehabilitation system used to quantify muscle strength and range of motion, as well as quantify compound physical abilities needed for the performance of functional tasks.
BTE TECHNOLOGIES, INC.
Prism1
In Commercial Distribution

  • 10850390007380 ()


  • Biomechanical function analysis system, force-testing, stationary

EvalTech - 10850390007328

A rehabilitation system used to quantify muscle strength and range of motion, as well as quantify compound physical abilities needed for the performance of functional tasks.
BTE TECHNOLOGIES, INC.
EvalTech
In Commercial Distribution

  • 10850390007328 ()


  • Biomechanical function analysis system, force-testing, stationary
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