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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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Med4 Elite - 00812120002877

System, Med4 Elite, Brazil, English
Avanos Medical, Inc.
650500-EN07
In Commercial Distribution

  • 00812120002877 ()


  • Circulating-fluid localized thermal/compression therapy system control unit

Med4 Elite - 00812120002754

System, Med4 Elite, Australia, English
Avanos Medical, Inc.
650500-EN09
In Commercial Distribution

  • 00812120002754 ()


  • Circulating-fluid localized thermal/compression therapy system control unit

Med4 Elite - 00812120002716

System, Med4 Elite, India, English
Avanos Medical, Inc.
650500-EN05
In Commercial Distribution

  • 00812120002716 ()


  • Circulating-fluid localized thermal/compression therapy system control unit

PHILIPS HeartStart OnSite - 00884838051478

OnSite, US English, Super Bundle
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
860367
Not in Commercial Distribution

  • 00884838051478 ()
860367

  • Non-rechargeable public automated external defibrillator

Philips Respironics - 00884838020047

V60 Ventilator, English Opt: None
Respironics California, Inc.
V60
In Commercial Distribution

  • 00884838020047 ()
1053616

  • Portable electric ventilator

Shaver interface Cable C15 - 07350021984340

For connecting Double Pump RF or Double Pump to Biomet Sports Medicine PowerTek II Plus
INSIGHTRA MEDICAL, INC.
1407264
In Commercial Distribution

  • 07350021984340 ()


  • Electrical-only medical device connection cable, reusable

ROLLER FOAM FULL ROLL 36" LONG X 6" WIDE ALIMED 3/CS - 00733657290684

No Description
ALIMED, INC.
3171603
In Commercial Distribution

  • 00733657290684 ()
  • 00733657298987 ()


  • Pilates reformer exerciser

LightForce EXPi - 00854103007059

Mains powered, infrared phototherapy and nail laser phototherapy device emitting up to 25 W at 980/810nm in CW or pulsed modes with a 10" touch screen display.
LITECURE LLC
LTS-2500
In Commercial Distribution

  • 00854103007059 ()


  • Musculoskeletal/physical therapy laser, professional
  • Nail laser phototherapy unit

Sirona - 00851074007149

Sirona B Android App
DATRIX LLC
RX22711
In Commercial Distribution

  • 00851074007149 ()


  • Telemetric electrocardiographic ambulatory recorder

Sirona - 00851074007132

Sirona B iOS App
DATRIX LLC
RX22674
In Commercial Distribution

  • 00851074007132 ()


  • Telemetric electrocardiographic ambulatory recorder
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