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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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.decimal Astroid Planning App 3.x - 00851147007120

The Astroid Planning App is a cloud based software used for treatment planning of proton radiation therapy treatments.
DECIMAL, INC.
3.x
In Commercial Distribution

  • 00851147007120 ()


  • Radiation therapy software

Eversense® NOW Mobile App iOS - 00817491021267

Eversense NOW Remote Monitoring mobile application (iOS) is intended to be a secondary device used to remotely view an Eversense CGM System user’s glucose information.
SENSEONICS, INCORPORATED
FG-5901-01-300
In Commercial Distribution

  • 00817491021267 ()
FG-5901-01-300

  • Implantable glucose monitoring system

Resilience – By Inner Armor App iOS - 07540191000630

No Description
Thought Technology Ltd.
SA4515
In Commercial Distribution

  • 07540191000630 ()


  • Psychophysiological biofeedback system

Orpheus CAST Mobile App Android OS - 07290017025124

A native iOS and Android mobile application also compatible with iPad. It is used to: • Locate patients according to patient ID • Locate scheduled procedures by connecting to modality worklist • Capture videos, images and audio files to be included in the study case. • Add notes and tags to each file (asset). • Upload any file to the Orpheus System • Manually or automatically delete files from the file library
ORPHEUS MEDICAL LTD
01
In Commercial Distribution

  • 07290017025124 ()
ML-EG30001

  • Radiology information system application software

Orpheus CAST Mobile App iOS + Android - 07290017025100

A native iOS and Android mobile application also compatible with iPad. It is used to: • Locate patients according to patient ID • Locate scheduled procedures by connecting to modality worklist • Capture videos, images and audio files to be included in the study case. • Add notes and tags to each file (asset). • Upload any file to the Orpheus System • Manually or automatically delete files from the file library
ORPHEUS MEDICAL LTD
01
In Commercial Distribution

  • 07290017025100 ()
MLL-EG30001

  • Radiology information system application software

3M™ Unitek™ - 00652221114938

SmartClip(TM) Dimpled Nitinol Super-Elastic OrthoForm(TM) II Square U .016 U/Use 10/Pk
3M UNITEK CORPORATION
9296-807
In Commercial Distribution

  • 80652221114934 ()
  • 00652221114938 ()
9296-807

  • Orthodontic archwire

3M™ Unitek™ - 00652221114914

SmartClip(TM) Dimpled Nitinol Super-Elastic OrthoForm(TM) II Square U .014 U/Use 10/Pk
3M UNITEK CORPORATION
9296-805
In Commercial Distribution

  • 80652221114910 ()
  • 00652221114914 ()
9296-805

  • Orthodontic archwire

3M™ Unitek™ - 00652221081988

Unitek(TM) Permachrome Standard Stainless Steel Standard Form U .016x.022 U/Use 50/Pk
3M UNITEK CORPORATION
4300-171
In Commercial Distribution

  • 80652221081984 ()
  • 00652221081988 ()
4300-171

  • Orthodontic archwire

Pinnacle - 00190730010933

Pinnacle 022 Roth U/L 5x5 Hks 345, OS Pad U/L 4/5 SPK
ORTHO TECHNOLOGY, INC.
360-92-2031
In Commercial Distribution

  • 00190730010933 ()


  • Orthodontic bracket, metal

Pinnacle - 00190730010926

Pinnacle 022 Roth U/L 5x5 Hks 3, OS Pad U/L 4/5 SPK
ORTHO TECHNOLOGY, INC.
360-92-2030
In Commercial Distribution

  • 00190730010926 ()


  • Orthodontic bracket, metal

Pinnacle - 00190730010506

Pinnacle 018 Roth U/L 5x5 Hks 345, OS Pad U/L 4/5 SPK
ORTHO TECHNOLOGY, INC.
360-91-2031
In Commercial Distribution

  • 00190730010506 ()


  • Orthodontic bracket, metal

Pinnacle - 00190730010490

Pinnacle 018 Roth U/L 5x5 Hks 3, OS Pad U/L 4/5 SPK
ORTHO TECHNOLOGY, INC.
360-91-2030
In Commercial Distribution

  • 00190730010490 ()


  • Orthodontic bracket, metal

Pinnacle - 00190730010001

Pinnacle 022 MC(0T) U/L 5x5 SPK, OS Pad U/L 4/5 SPK
ORTHO TECHNOLOGY, INC.
360-22-2060
Not in Commercial Distribution

  • 00190730010001 ()


  • Orthodontic bracket, metal

Pinnacle - 00190730009968

Pinnacle 022 MC U/L 5x5 Hks 345, OS Pad U/L 4/5 SPK
ORTHO TECHNOLOGY, INC.
360-22-2031
In Commercial Distribution

  • 00190730009968 ()


  • Orthodontic bracket, metal

Pinnacle - 00190730009951

Pinnacle 022 MC U/L 5x5 Hks 3, OS Pad U/L 4/5 SPK
ORTHO TECHNOLOGY, INC.
360-22-2030
In Commercial Distribution

  • 00190730009951 ()


  • Orthodontic bracket, metal

Votion - 00190730009104

Votion 022 Roth U/L 5x5 Hks 345, OS Pad U/L 4/5 SPK
ORTHO TECHNOLOGY, INC.
350-92-2031
In Commercial Distribution

  • 00190730009104 ()


  • Orthodontic bracket, metal

Votion - 00190730009098

Votion 022 Roth U/L 5x5 Hks 3, OS Pad U/L 4/5 SPK
ORTHO TECHNOLOGY, INC.
350-92-2030
In Commercial Distribution

  • 00190730009098 ()


  • Orthodontic bracket, metal

Votion - 00190730008671

Votion 018 Roth U/L 5x5 Hks 345, OS Pad U/L 4/5 SPK
ORTHO TECHNOLOGY, INC.
350-91-2031
In Commercial Distribution

  • 00190730008671 ()


  • Orthodontic bracket, metal

Votion - 00190730008664

Votion 018 Roth U/L 5x5 Hks 3, OS Pad U/L 4/5 SPK
ORTHO TECHNOLOGY, INC.
350-91-2030
In Commercial Distribution

  • 00190730008664 ()


  • Orthodontic bracket, metal

Votion - 00190730008138

Votion 022 MC U/L 5x5 Hks 345, OS Pad U/L 4/5 SPK
ORTHO TECHNOLOGY, INC.
350-22-2031
In Commercial Distribution

  • 00190730008138 ()


  • Orthodontic bracket, metal
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