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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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No Description
SWIFT HEALTH SYSTEMS INC.
Digital Engancement
In Commercial Distribution

  • 00850018135122 ()
8131

  • Orthodontic appliance/positioning tray kit
No Description
SWIFT HEALTH SYSTEMS INC.
Lower Fitting Kit
In Commercial Distribution

  • 00850018135054 ()
85003

  • Orthodontic appliance/positioning tray kit
No Description
SWIFT HEALTH SYSTEMS INC.
Fitting Kit
In Commercial Distribution

  • 00850018135047 ()
85000

  • Orthodontic appliance/positioning tray kit
No Description
SWIFT HEALTH SYSTEMS INC.
Upper Fitting Kit
In Commercial Distribution

  • 00850018135030 ()
85002

  • Orthodontic appliance/positioning tray kit
No Description
SWIFT HEALTH SYSTEMS INC.
Upper Patient Kit
In Commercial Distribution

  • 00850018135016 ()
8111

  • Orthodontic appliance/positioning tray kit
No Description
SWIFT HEALTH SYSTEMS INC.
Standard Patient Kit
In Commercial Distribution

  • 00850018135009 ()
8101

  • Orthodontic appliance/positioning tray kit
LICENCE CS MODEL+ V5 ALIGNER CAPABILITY
CARESTREAM DENTAL LLC
5944483
In Commercial Distribution

  • 60192155944482 ()
5944483

  • CAD/CAM software
CS MODEL+
CARESTREAM DENTAL LLC
CS Model+
Not in Commercial Distribution

  • 60192155942716 ()
5942719

  • CAD/CAM software
ClinCheck Pro 6
Align Technology, Inc.
SW-0000159
In Commercial Distribution

  • 00816063021360 ()


  • Orthodontic progressive aligner
hi-PS (Programming Software) Fitting Software, Solo
INTRICON CORPORATION
hi-PS Solo
In Commercial Distribution

  • 00858177007151 ()
23126

  • Hearing aid wireless-fitting computer-aided set
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