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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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ACUMED - 10806378039850

AI Acutrak® Comp Screw Handle Assy
Acumed LLC
80-0097
In Commercial Distribution

  • 10806378039850 ()


  • Surgical instrument handle, non-torque-limiting

Millennium - 00190776209667

Visual Obturator with AI sheath scope lock
Avalign Technologies, Inc.
72-3130073
In Commercial Distribution

  • 00190776209667 ()


  • ENT examination/treatment system

Millennium - 00190776189686

FIBER OPTIC CABLE FOR RETRACTORS AI ADAPTOR
Avalign Technologies, Inc.
MFOC-10R
In Commercial Distribution

  • 00190776189686 ()


  • Electrical-only medical device connection cable, reusable

Millennium - 00190776189570

Fiberoptic Cable A AF Blue AI Cable
Avalign Technologies, Inc.
FTIMG166288BL
In Commercial Distribution

  • 00190776189570 ()


  • Electrical-only medical device connection cable, reusable

Millennium - 00190776191177

FIBER LIGHT CABLE w AI INSTRUMENT CONNECTORS
Avalign Technologies, Inc.
72-9819
In Commercial Distribution

  • 00190776191177 ()


  • Fibreoptic retractor handle

NA - 07630031759030

Optiloc® Laboratory Instrument, stainless steel/AI
Institut Straumann AG
Non-invasive Instruments
In Commercial Distribution

  • 07630031759030 ()
3202.0002-OPT

  • Dental precision attachment fitting/adjustment tool

Automated Wound Measurements - 00860475000383

No Description
EPIC SYSTEMS CORPORATION
1
In Commercial Distribution

  • 00860475000383 ()


  • Wound management image-analysis software

Minuteful for Wound at Home - 17290017272877

The Minuteful for Wound device is a comprehensive wound management system designed to assist in the management of chronic wounds. It is intended to support healthcare professionals in the clinical assessment of wounds by measuring, documenting, monitoring, and managing information relevant to the progression and treatment of chronic wounds. The device comprises Calibration Stickers, a Web Portal for healthcare professionals to review and manage wound data, and two separate smartphone applications. These applications are utilized for the collection of wound data: one for healthcare professionals and one for lay users under the guidance and supervision of healthcare professionals.
HEALTHY.IO LTD
WND PNT.EN.GEN
In Commercial Distribution

  • 07290017272504 ()
  • 17290017272877 ()


  • Wound management image-analysis software

Minuteful for Wound - 17290017272716

The Minuteful for Wound device is a comprehensive wound management system designed to assist in the management of chronic wounds. It is intended to support healthcare professionals in the clinical assessment of wounds by measuring, documenting, monitoring, and managing information relevant to the progression and treatment of chronic wounds. The device comprises Calibration Stickers, a Web Portal for healthcare professionals to review and manage wound data, and two separate smartphone applications. These applications are utilized for the collection of wound data: one for healthcare professionals and one for lay users under the guidance and supervision of healthcare professionals.
HEALTHY.IO LTD
MNT WND.EN.GN2
In Commercial Distribution

  • 07290017272504 ()
  • 17290017272716 ()


  • Wound management image-analysis software

Minuteful for Wound - 17290017272709

The Minuteful for Wound device is intended to provide healthcare professionals with a tool to document, track, and monitor chronic wounds which will aid in wound care management.
HEALTHY.IO LTD
MNT WND.EN.GEN
In Commercial Distribution

  • 07290017272504 ()
  • 17290017272709 ()


  • Wound management image-analysis software
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