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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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ImmersiveTouch4 is a hardware accessory to ImmersiveTouch simulator. It supports ImmersiveTouch simulator to function as pre-operative software for simulating and evaluating surgical treatment options.
IMMERSIVETOUCH, INC.
ImmersiveTouch4
In Commercial Distribution

  • B940IVZBKIT0 ()


  • Portable computer
Tuning Device
OTTO BOCK HEALTHCARE
560X11=V2
In Commercial Distribution

  • B155EM40 ()
  • 04032767832866 ()


  • Portable computer
Wireless Tuning Device
BIONX MEDICAL TECHNOLOGIES, INC.
em4
In Commercial Distribution

  • B155EM40 ()


  • Portable computer
BiOM T2 Wireless Tuning Device
BIONX MEDICAL TECHNOLOGIES, INC.
2001219
In Commercial Distribution

  • B15520012190 ()


  • Portable computer
fastmill.io system (fastdesign.io computer + fastmill.io)
Prismatik Dentalcraft, Inc
70-1181-MIL0016
In Commercial Distribution

  • D745701181MIL00160 ()
70-1181-MIL0016

  • CAD/CAM software
SleepScout Computer Unit for recording/viewing SleepScout acquisition data in real time on a PC.
Cleveland Medical Devices Inc.
Computer Unit
Not in Commercial Distribution

  • B14350201490 ()
502-0149

  • Electroencephalograph
Sapphire Computer Unit for recording/viewing Sapphire acquisition data in real time on a PC.
Cleveland Medical Devices Inc.
Computer Unit
Not in Commercial Distribution

  • B14350101320 ()
502-0132

  • Electroencephalograph
Aadva™ IOS 100: IOS cart, IOS Handpiece (via USB connection), CPU (onboard computer), G.U.I. touchscreen, holder inserts bags of 10, plug, IFUs (includes: Quick Start Guide & Owners manual).
Gc America Inc.
940502
In Commercial Distribution

  • J0229405021 ()
940502

  • Dental milling system, CAD/CAM, laboratory
No Description
HELENA LABORATORIES CORPORATION
1341002
In Commercial Distribution

  • M52513410020 ()


  • Pipetting system IVD
Metabolic Measurement System
Aei Technologies, Inc.
MAXIIa
In Commercial Distribution

  • B9671504140 ()
150414

  • Metabolic measurement trolley
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