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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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Clarius Ultrasound Scanner - 07540205000397

No Description
Clarius Mobile Health Corp
App - iOS
In Commercial Distribution

  • 07540205000397 ()
12-01-00003

  • Ultrasound imaging system application software
  • Radiological PACS software

Persona Medical - 00851362008087

IOS & Android based APP used to control Evok 1600 OTE/BTE device.
Persona Medical
Persona APP
In Commercial Distribution

  • 00851362008087 ()


  • Air-conduction hearing aid, behind-the-ear

RXEars - 00851362008025

IOS & Android based APP used to control RxEars RX7 BTE device.
Persona Medical
RxEars APP
In Commercial Distribution

  • 00851362008025 ()


  • Air-conduction hearing aid, behind-the-ear

3DIEMME RealGUIDE - 08050038830003

Mobile version
3DIEMME SRL
RealGUIDE APP
In Commercial Distribution

  • 08050038830003 ()


  • CAD/CAM software

OrthoFlex - 00190730002532

OrtFlx Com McLaughlin 022 LL5 Rx -17º Tor. +2º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-874
In Commercial Distribution

  • 00190730002532 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730002525

OrtFlx Com McLaughlin 022 LR5 Rx -17º Tor. +2º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-873
In Commercial Distribution

  • 00190730002525 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730002495

OrtFlx Com McLaughlin 022 LL4 Rx -12º Tor. +2º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-864
In Commercial Distribution

  • 00190730002495 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730002488

OrtFlx Com McLaughlin 022 LR4 Rx -12º Tor. +2º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-863
In Commercial Distribution

  • 00190730002488 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730002228

OrtFlx Com McLaughlin 022 UL2 Rx +10º Tor. +8º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-812
In Commercial Distribution

  • 00190730002228 ()


  • Orthodontic bracket, plastic, single-use

OrthoFlex - 00190730002204

OrtFlx Com McLaughlin 022 UR2 Rx +10º Tor. +8º Ang.(10PK)
ORTHO TECHNOLOGY, INC.
COM-811
In Commercial Distribution

  • 00190730002204 ()


  • Orthodontic bracket, plastic, single-use
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