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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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Restore is a patient lubricant intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.
GOOD CLEAN LOVE, INC.
1.0 oz
In Commercial Distribution

  • 00893268000130 ()
  • 30893268000131 ()
900250

  • General-body orifice lubricant, non-sterile
This is a medical device.The dental treatment unit running as a desktop unit is intended for use in the field of dentistry. It is designed for the operation of an electrically operated small voltage motor. Area of application is in the field of endodontics and tooth preparation. The ELECTROmatic is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. This device is designed for use by a trained professional in the field of general dentistry.
KaVo Dental GmbH
1.003.1109
In Commercial Distribution

  • EKAV100311090 ()
31 ES

  • Dental power tool system handpiece, line-powered
Windows 10 Tower which is part of a multi-patient physiologic monitoring system.
LIFE SENSING INSTRUMENTS, INC.
HTS820 Windows 10 BLE
In Commercial Distribution

  • 00857769008026 ()


  • Electrocardiography telemetric monitoring system
Windows 10 Tower which is part of a multi-patient physiologic monitoring system
LIFE SENSING INSTRUMENTS, INC.
HTS820 Windows 10
In Commercial Distribution

  • 00857769008002 ()


  • Multiple-patient intensive/general healthcare physiologic monitoring system
Genie Medical 2019.1 BAHS, USB ISO file for this software is 5712149025336
Oticon Medical AB
197603
In Commercial Distribution

  • 05712149025329 ()
M52650

  • Anchored bone-conduction hearing implant system
Genie Medical BAHS 2019.1 DVD ISO file for this software is 5712149025336
Oticon Medical AB
197965
In Commercial Distribution

  • 05712149025312 ()
197965

  • Anchored bone-conduction hearing implant system
Windows 7 Tower which is part of a multi-patient physiologic monitoring system
LIFE SENSING INSTRUMENTS, INC.
HTS820 Windows 7
In Commercial Distribution

  • 00864037000330 ()


  • Multiple-patient intensive/general healthcare physiologic monitoring system
PMI Operative Cholangiogram Catheter; tubing is 76cm in length, 16ga with a
PROGRESSIVE MEDICAL, INC.
PMIORCA
In Commercial Distribution

  • 10812608021069 ()
  • 00812608021062 ()


  • Interventional radiology percutaneous-access kit, single-use
Lumbosacral support. Made of cloth, the device is worn on the body
Guangzhou Xinbo Electronic Co., Ltd.
NN-LB-Black
In Commercial Distribution

  • 06970742221756 ()


  • Lumbosacral spine orthosis, pendulous abdomen support
The Trabectome I/A Console (110V) is an aspiration pump intended for use in general surgery applications where aspiration of irrigation waste and waste fluid is desired.
NEOMEDIX CORPORATION
550014
In Commercial Distribution

  • 00854028002023 ()
550014-01

  • Ophthalmic irrigation/aspiration pump
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