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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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FlexDex Needle Driver - 00860004002109

No Description
FlexDex Surgical
FD-335 ND
Not in Commercial Distribution

  • 00860004002116 ()
  • 00860004002109 ()


  • Suturing needle holder, single-use

Abiomed Breethe OXY-1 System - 00860001797947

Pump Driver Service Replacement Kit
Breethe, Inc.
001-0301-003
In Commercial Distribution

  • 00860001797947 ()
001-0301-003

  • Cardiopulmonary bypass system, non-roller type

MIRARI Cold Plasma Driver - 00860013508616

No Description
General Vibronics, LLC
GVM2
In Commercial Distribution

  • 00860013508616 ()


  • Medium-wave diathermy treatment system generator

EmbedMed - 00860009815735

Patient-specific, Maxillofacial Anatomical Model, Digital
3D LIFEPRINTS UK LTD
CMFDAM
Not in Commercial Distribution

  • 00860009815735 ()


  • Custom-made organ/bone anatomy model

EmbedMed - 00860009815704

Patient-specific, Maxillofacial Anatomical Model, Non-sterile
3D LIFEPRINTS UK LTD
CMFAMNS
In Commercial Distribution

  • 00860009815704 ()


  • Custom-made organ/bone anatomy model

Universal SmartECG - 00857175006173

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

H&H Situation Instrument Tray Kit - 00857048006057

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

K-wire - 00856719002237

2.0mm x 229mm K-wire
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
WIR2-229
In Commercial Distribution

  • 00856719002237 ()

  • tool/instrument
WIR2-229

  • Manual wire driver

MatrixPRO Driver Battery Pack, Sterile - 00862377000119

No Description
PRO-DEX, INC.
05.000.021S
In Commercial Distribution

  • 00862377000119 ()
  • 10862377000116 ()
  • 20862377000113 ()


  • Disposable battery pack

REVIAN RED - 00862712000309

REVIAN RED is a non-invasive, hands-free device indicated to treat androgenetic alopecia in both men and women. It is operated via a mobile application to promote hair growth using Modulated Light Therapy (MLT) for a recommended 10-minute daily treatment. REVIAN RED is a system comprised of a wearable soft textile Cap using driver electronics,a rechargeable battery, and integrated light emitting diode (LED) flexible printed circuit board. REVIAN RED is designed as an over-the-counter (OTC) home-based device to treat the entire scalp area of the user and is controlled via a wireless Bluetooth connection to a mobile application operating on a wireless device.
Revian, Inc.
101
In Commercial Distribution

  • 00862712000309 ()

  • Width: 20 Centimeter
  • Weight: 155 Gram
  • Length: 22.86 Centimeter
  • Height: 15.87 Centimeter
10001

  • Hair growth laser device
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