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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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DreamMapper Web NA Instance v 2.13
Respironics, Inc.
2.13
In Commercial Distribution

  • 00606959051256 ()
1101679

  • Self-care monitoring/reporting software
DreamMapper Web EU Instance v 2.10
Respironics, Inc.
2.10
In Commercial Distribution

  • 00606959049031 ()
1128262

  • Self-care monitoring/reporting software
No Description
Sugarmate, LLC
1008181
In Commercial Distribution

  • 00850018992619 ()


  • Self-care monitoring/reporting software
ResolutionMD® Web is a software-based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and 3D visualization of medical image data. It provides for communication, storage, reformatting, rendering, and display of DICOM 3.0 compliant image data derived from various sources including CT and MRI.
ResolutionMD Inc.
RMD-WEB-I
Not in Commercial Distribution

  • B037RESMDWEB0 ()


  • Radiological PACS software
Showmotion software can be used to control motion sensors hardware in order to track kinematics of upper/lower body by means of specific biomechanical protocols. Showmotion software can also be used as a stand-alone system when opening a subject's database, playing back previously recorded analyses, and when generating specific reports or comparison analyses. In this configuration there is no need to connect with the hardware sensors.
NCS LAB SRL
SHWM01SW1
In Commercial Distribution

  • 08051122041091 ()


  • Biomechanical function analysis/rehabilitation software
No Description
Biomet Orthopedics, LLC
1312-20-255
In Commercial Distribution

  • 00887868013386 ()

  • 2.5 mm
131220255

  • Orthopaedic fixation plate, non-bioabsorbable
No Description
Biomet Orthopedics, LLC
1312-20-155
In Commercial Distribution

  • 00887868013317 ()

  • 1.5 mm
131220155

  • Orthopaedic fixation plate, non-bioabsorbable
EARLOOP, TUTEM- KEEP IT TO YOURSELF.
Alpha Pro Tech, Inc.
6055-6 KEEP IT TO YOURSELF
Not in Commercial Distribution

  • 10817583020403 ()
  • 00817583020406 ()
6055-6 KEEP IT TO YOURSELF

  • Surgical hood
Implant Abutment neck diameter ( 3.5 to 5.0mm), 9mm height, between 40° and 60° as required - prescribed for patient by Dentist
Suncoast Dental, Inc
Custom Abutment
Not in Commercial Distribution

  • 00083208700002 ()

  • Height: 9 Millimeter
  • Custom Implant Abutment Angle between 40° and 60°
Custom PN 40° to 60°

  • Screw endosteal dental implant, two-piece
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - Upgrade from SOFT-NH300-2/3 to SOFT-NH301-4,K The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NH300 Ana to 301
In Commercial Distribution

  • 07290110252717 ()
SW NH300 Ana to 301

  • Electrocardiographic long-term ambulatory recording analyser
Software as a medical device (SaMD) for some Lilly medicines which provides access to medication reminders and customer support services; Operates on Android devices (various manufacturers).
ELI LILLY AND COMPANY
MA9131 Android
In Commercial Distribution

  • 00300021109554 ()
MA9131001AM

  • Medication reminder application software
Tala Android - OTC Hearing aid Ety part #20138
ETYMOTIC RESEARCH, INC.
Tala Android
In Commercial Distribution

  • 00846430005839 ()


  • Air-conduction hearing aid, in-the-ear
Young Traditional Web Latch Prophy Cup, Firm, Long, White Web Cup, Metal Latch Type
YOUNG DENTAL MANUFACTURING I, LLC
055601
In Commercial Distribution

  • 10302730556015 ()
  • 00302730556018 ()
055601

  • Dental polishing cup, single-use
Young Petite Web Prophy Cup, Latex Free, Firm, Short, Blue Web Cup, Screw Type
YOUNG DENTAL MANUFACTURING I, LLC
054705
In Commercial Distribution

  • 10302730547051 ()
  • 00302730547054 ()
054705

  • Dental polishing cup, single-use
Young Petite Web Prophy Cup, Latex Free, Firm, Short, Blue Web Cup, Screw Type
YOUNG DENTAL MANUFACTURING I, LLC
054701
In Commercial Distribution

  • 10302730547013 ()
  • 00302730547016 ()
054701

  • Dental polishing cup, single-use
Young Petite Web Prophy Cup, Latex Free, Soft, Short, Purple Web Cup, Screw Type
YOUNG DENTAL MANUFACTURING I, LLC
054605
In Commercial Distribution

  • 10302730546054 ()
  • 00302730546057 ()
054605

  • Dental polishing cup, single-use
Young Petite Web Prophy Cup, Latex Free, Soft, Short, Purple Web Cup, Screw Type
YOUNG DENTAL MANUFACTURING I, LLC
054601
In Commercial Distribution

  • 10302730546016 ()
  • 00302730546019 ()
054601

  • Dental polishing cup, single-use
Young Petite Web Prophy Cup, Latex Free, Soft, Short, Purple Web Cup, Latch Type
YOUNG DENTAL MANUFACTURING I, LLC
295868
In Commercial Distribution

  • 10302730001683 ()
  • 00302730001686 ()
295868

  • Dental polishing cup, single-use
Hearing Device incorporating wireless protocol to be controlled with Persona APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.
Persona Medical
Sombra XS
In Commercial Distribution

  • 00851362008124 ()


  • Air-conduction hearing aid, behind-the-ear
Hearing Device incorporating wireless protocol to be controlled with Persona APP for basic changes to frequency response of device, for example: volume, memory, bass, treble...etc.,. Also, pick up phone calls and connect to a remote microphone/audio peripherals.
Persona Medical
Sombra VS
In Commercial Distribution

  • 00851362008117 ()


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