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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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Gutta percha plastic carrier obturator
US ENDODONTICS, LLC
ES5506O
In Commercial Distribution

  • 10810047644474 ()
  • 00810047644477 ()
ES5506O

  • Warm-bonded endodontic obturation system obturator
Gutta percha plastic carrier obturator
US ENDODONTICS, LLC
EE5006O
In Commercial Distribution

  • 10810047644467 ()
  • 00810047644460 ()
EE5006O

  • Warm-bonded endodontic obturation system obturator
Gutta percha plastic carrier obturator
US ENDODONTICS, LLC
EE4506O
In Commercial Distribution

  • 10810047644450 ()
  • 00810047644453 ()
EE4506O

  • Warm-bonded endodontic obturation system obturator
Pink Gutta Percha Core Thermal obturator
US ENDODONTICS, LLC
EE5006C
In Commercial Distribution

  • 10810047644443 ()
  • 00810047644446 ()
EE5006C

  • Warm-bonded endodontic obturation system obturator
Pink Gutta Percha Core Thermal obturator
US ENDODONTICS, LLC
EE4506C
In Commercial Distribution

  • 10810047644436 ()
  • 00810047644439 ()
EE4506C

  • Warm-bonded endodontic obturation system obturator
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
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
Foot Control
W & H Dentalwerk Bürmoos GmbH
05083300
Not in Commercial Distribution

  • J021050833000 ()
  • J021050833001 ()


  • Foot-switch, electrical
No Description
Biomet Orthopedics, LLC
14393
In Commercial Distribution

  • 00887868002397 ()

  • 3.5MM
14393

  • Manual orthopaedic bender, reusable
No Description
BIOGENEX LABORATORIES
AX993-YCD
In Commercial Distribution

  • 00810119677365 ()
AX993-YCD

  • S100 protein IVD, antibody
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