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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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VividTrac - 00860003538029

VividTrac® Pediatric VT-P100 (Single Unit)
VIVID MEDICAL INC.
VT-P100
In Commercial Distribution

  • 00860003538029 ()
  • 00860003538036 ()
800-0003-001

  • Channelled video intubation laryngoscope

VividTrac - 00860003538005

VividTrac® Adult VT-A100 (Single Unit)
VIVID MEDICAL INC.
VT-A100
In Commercial Distribution

  • 00860003538005 ()
  • 00860003538012 ()
800-0001-001

  • Channelled video intubation laryngoscope

LifeWindow - 00860003504017

Multi-Parameter Physiological Patient Monitor
DIGICARE BIOMEDICAL TECHNOLOGY, INC.
LW8 Lite
In Commercial Distribution

  • 00860003504017 ()


  • General-purpose multi-parameter bedside monitor
  • Neonatal multi-parameter bedside monitor

Lexie Hearing - 00860003469880

Lexie Lumen Duo Metalic Black - Online
HEARX GROUP (PTY) LTD
Lexie Lumen Duo Metalic Black
In Commercial Distribution

  • 00860003469880 ()
LLO00002MB

  • Air-conduction hearing aid, receiver-in-canal

Lexie Hearing - 00860003469866

Lexie Lumen Duo Bronze - Online
HEARX GROUP (PTY) LTD
Lexie Lumen Duo Bronze
In Commercial Distribution

  • 00860003469866 ()
LLO00002BR

  • Air-conduction hearing aid, receiver-in-canal

Lexie Hearing - 00860003469842

Lexie Lumen Duo Light Gray - Online
HEARX GROUP (PTY) LTD
Lexie Lumen Duo Light Gray
In Commercial Distribution

  • 00860003469842 ()
LLO00002GR

  • Air-conduction hearing aid, receiver-in-canal

hearX - 00860003469828

hearScope consists of a handheld video otoscope with a light source and ear speculum of various sizes that connects to an Android smartphone (can be user-supplied).
HEARX GROUP (PTY) LTD
hearScope
In Commercial Distribution

  • 00860003469828 ()


  • Otoscope, direct

hearX - 00860003469811

No Description
HEARX GROUP (PTY) LTD
hearTest
In Commercial Distribution

  • 00860003469811 ()


  • Tone audiometer

Lexie Hearing - 00860003469804

Lexie Lumen self-fitting Beige hearing aid - Duo
HEARX GROUP (PTY) LTD
Lumen Duo Beige
In Commercial Distribution

  • 10860003469801 ()
  • 00860003469804 ()
Lumen 155

  • Air-conduction hearing aid, behind-the-ear

kegg - 00860003372906

Fertility Tracking Monitor
Lady Technologies, Inc.
K1
In Commercial Distribution

  • 00860003372906 ()


  • Natural conception assistance kit
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