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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Lumify Diagnostic Ultrasound System iOS Release 5.1
Philips Ultrasound LLC
795161
In Commercial Distribution

  • 00884838124141 ()


  • General-purpose ultrasound imaging system
Tandem t:slim Mobile Application, iOS version 2.9
Tandem Diabetes Care, Inc.
1014707
In Commercial Distribution

  • 00389152470740 ()


  • Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm
G5 Mobile IOS App Stand Alone Software
Dexcom, Inc.
SW10611
In Commercial Distribution

  • 00386270000002 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
DreamMapper App iOS, Asia-Pacific Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054288 ()
1127959

  • Self-care monitoring/reporting software
DreamMapper App iOS, EMEA Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054271 ()
1128264

  • Self-care monitoring/reporting software
DreamMapper iOS, North American Instance, version 2.17
Respironics, Inc.
2.17
In Commercial Distribution

  • 00606959054264 ()
1101478

  • Self-care monitoring/reporting software
Titan Design 4.8mm Tg Hex Abutment Analog
TITAN IMPLANT INC
TN-48TGHAA
In Commercial Distribution

  • 00842448112330 ()


  • Dental implant abutment analog, laboratory
4.8mm TG Post Abutment Analog Height 7.0mm
TITAN IMPLANT INC
T-7TGPA
In Commercial Distribution

  • 00842448112057 ()


  • Dental implant abutment analog, laboratory
XiVE® TG Lab Set Bridge cast-to
Dentsply Implants Manufacturing GmbH
32259905
Not in Commercial Distribution

  • EFRI322599052 ()
25-9905

  • Dental implant suprastructure kit
XiVE® TG Lab Set Bridge castable
Dentsply Implants Manufacturing GmbH
32259900
Not in Commercial Distribution

  • EFRI322599002 ()
25-9900

  • Dental implant suprastructure kit
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