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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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DermLite Foto X Plus
DermLite LLC
DLFX-Plus
In Commercial Distribution

  • 00855997006883 ()
DLFX-Plus

  • Dermatoscope, optical
Resin, denture, relining, repairing,rebasing
Kulzer GmbH
64708063
In Commercial Distribution

  • J014647080630 ()
64708063

  • Dental appliance fabrication material, thermoplastic
No Description
Biomet Orthopedics, LLC
13120
In Commercial Distribution

  • 00880304529267 ()

  • 1.6 MM Ø 350 MM LENGTH
13120

  • External orthopaedic fixation system, single-use
No Description
Biomet Orthopedics, LLC
13130
In Commercial Distribution

  • 00880304529199 ()

  • 2.0 MM Ø 350 MM LENGTH
13130

  • External orthopaedic fixation system, single-use
Range Check X ll
SYSMEX CORPORATION
130-4003-0
Not in Commercial Distribution

  • 14987562460257 ()

  • Total Volume: 2 Milliliter


  • Full blood count IVD, control
Range Check X lll 24X3.0ML WBC/RBC/PLT
SYSMEX CORPORATION
218981
Not in Commercial Distribution

  • 14987562460387 ()

  • Total Volume: 3 Milliliter


  • Full blood count IVD, control
A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.
Pride Mobility Products Corp
S4401/SC4401
In Commercial Distribution

  • 00606509300018 ()
N/A

  • Assistive scooter, electric-motor-driven
A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.
Pride Mobility Products Corp
S4001/SC4001
In Commercial Distribution

  • 00606509300001 ()
N/A

  • Assistive scooter, electric-motor-driven
No Description
INTERVENTIONAL SPINE, INC
6022
In Commercial Distribution

  • 00811954012830 ()
6022

  • General internal orthopaedic fixation system implantation kit
No Description
INTERVENTIONAL SPINE, INC
6021
In Commercial Distribution

  • 00811954012823 ()
6021

  • General internal orthopaedic fixation system implantation kit
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