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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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TRAUMA KIT, 1211-1L LARGE RING, 1206-33 HEADBLOCK, 1206-11 TRACTION BAIL, 1201-8 TORQUE DRIVER
PMT CORPORATION
1211-6L4
In Commercial Distribution

  • 00650551094524 ()
1211-6L4

  • Cervical spine immobilization system, single-use
TRAUMA KIT, 1211-1L LARGE RING, 1206-32 HEADBLOCK, 1206-11 TRACTION BAIL, 1201-8 TORQUE DRIVER
PMT CORPORATION
1211-6L3
In Commercial Distribution

  • 00650551094517 ()
1211-6L3

  • Cervical spine immobilization system, single-use
TRAUMA KIT, 1211-1L LARGE RING, 1206-20 HEADBLOCK, 1206-11 TRACTION BAIL, 1201-8 TORQUE DRIVER
PMT CORPORATION
1211-6L1
In Commercial Distribution

  • 00650551094500 ()
1211-6L1

  • Cervical spine immobilization system, single-use
No Description
SYNCARDIA SYSTEMS, LLC
297043-001
In Commercial Distribution

  • 00858000003237 ()


  • Ventricular prosthesis system, pneumatically-powered
No Description
SYNCARDIA SYSTEMS, LLC
297032-100
In Commercial Distribution

  • 00858000003206 ()


  • Ventricular prosthesis system, pneumatically-powered
No Description
SYNCARDIA SYSTEMS, LLC
397001-001
In Commercial Distribution

  • 00858000003145 ()


  • Ventricular prosthesis system, pneumatically-powered
No Description
SYNCARDIA SYSTEMS, LLC
595000-001
In Commercial Distribution

  • 00858000003121 ()
  • 10858000003128 ()


  • Ventricular prosthesis system, pneumatically-powered
No Description
SYNCARDIA SYSTEMS, LLC
397002-001
In Commercial Distribution

  • 00858000003107 ()


  • Ventricular prosthesis system, pneumatically-powered
The Universal SmartECG is an ECG amplifier that connects to electrodes on a patient and a PC with Windows operating systems via a USB connection. The ECG amplifier detects electrical impulses from the patient and coverts them into a digital signal that can be displayed and recorded on the computer. The ECG system consists of a 12-lead ECG, multi-language Office Medic Software and VectraplexECG, a UL 60950 compliant host computer and accessories. The 12-lead ECG includes an analog front end designed to detect, amplify, filter, and output biopotential measurements in real time, a microprocessor to communicate and control the analog front end and system, short circuit protection, ESD protection, defibrillation isolation and protection, a green indication LED, 10 leadwires, lead off detection, USB communication to PC and Office Medic or VectraplexECG, and bootloader. The device is powered by the USB connector and is regulated to two separate supplies, a 3.3V digital supply and a 3.3V analog supply to respectively power the digital and analog circuitry. The 12-lead ECG outputs ECG waveform information via USB to the Office Medic or VectraplexECG Software that translates, filters, analyzes, and displays the ECG waveform in real time. The hardware contains an FTDI USB UART translator chip to install required USB drivers to the PC and allow appropriate data conversion to the PC during ECG measurement.
VECTRACOR INC
AHA
In Commercial Distribution

  • 00857175006173 ()
Z-7000-0500

  • Electrocardiograph, professional, multichannel
The H&H Situational Instrument Tray (SIT) Kit is a sterile, single use kit for performing many surgical procedures immediately. The SIT Kit provides a generic set of must-have instruments in a convenient vacuum-sealed bag ready for use. The SIT kit contains: A 5.5" Straight Crile Hemostat A 4.5" Straight Iris Scissors A 9.75" Medium Magill Forceps A 6" Mayo-Hegar needle driver, and A protective sterile field wrap
H&H MEDICAL CORPORATION
1
In Commercial Distribution

  • 00857048006057 ()
HHSIT01

  • General surgical procedure kit, non-medicated, single-use
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