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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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CathCheck Disposable Kit (Pre-assembled) - 00618874601034

CathCheck Disposable Kit (Pre-assembled) to be used with CompuFlo Epidural Computer Controlled Anesthesia System
Milestone Scientific Inc.
EPI-6010-03
In Commercial Distribution

  • 00618874601034 ()


  • Epidural anaesthesia set, non-medicated

MJS System 3 Upgrade - 00718175004067

Biodex Multi-Joint-System 3 Rev.1 UpGrade
BIODEX MEDICAL SYSTEMS, INC.
850-822
Not in Commercial Distribution

  • 00718175004067 ()
850-822

  • Biomechanical function analysis system, force-testing, stationary

System 4 Pro - 00718175004005

Biodex System 4 Pro
BIODEX MEDICAL SYSTEMS, INC.
850-000
In Commercial Distribution

  • 00718175004005 ()
850-000

  • Biomechanical function analysis system, force-testing, stationary

System 4 MVP - 00718175004401

System 4 MVP
BIODEX MEDICAL SYSTEMS, INC.
852-000
In Commercial Distribution

  • 00718175004401 ()
852-000

  • Biomechanical function analysis system, force-testing, stationary

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
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