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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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LiNA OperaScopeTM Lasso is intended for use in hysteroscopy procedures.
Lina Medical ApS
OP-LAS16-3
Not in Commercial Distribution

  • 05708265011537 ()
  • 05708265011544 ()
OP-LAS16-3

  • Mechanical-cutting endoscopic polypectomy snare
Paste used to polish teeth after dental restoration is complete
Bioclear Matrix Systems
Mint
In Commercial Distribution

  • D9497001111 ()


  • Dentifrice
EV29L is a 29 MHz high resolution transrectal side-fire transducer.
Exact Imaging Inc
EV29L
In Commercial Distribution

  • 00628055481034 ()
EV-29L

  • Rectal/vaginal ultrasound imaging transducer
SCT01 is the device for the measurement of body temperature.
YA HORNG ELECTRONIC CO., LTD.
SCT01
In Commercial Distribution

  • 04719873310067 ()
  • 14719873310064 ()


  • Intermittent electronic patient thermometer
SCT01 is the device for the measurement of body temperature.
YA HORNG ELECTRONIC CO., LTD.
SCT01
In Commercial Distribution

  • 04719873310012 ()
  • 14719873310019 ()


  • Intermittent electronic patient thermometer
The identifeye Camera System is a fundus ophthalmic camera reconditioned.
Identifeye Health Inc.
850-30004-00
In Commercial Distribution

  • 00850067214281 ()


  • Ophthalmic fundus camera
This product is intended to confirm airtight of the endoscope.
FUJIFILM CORPORATION
LT-7F
In Commercial Distribution

  • 04547410331615 ()


  • Invasive medical device leak tester, mechanical
This guide is used for the Position accuracy check needle.
FUJIFILM CORPORATION
NEEDLE GUIDE TEST E
In Commercial Distribution

  • 04547410211214 ()


  • Stationary mammographic x-ray system, digital
The Disposable Safety Lancet is intended for capillary blood sampling.
Stat Medical Devices, Inc.
Qwik-Lance Safety Lancet
In Commercial Distribution

  • 30709334883884 ()
  • 00709334883883 ()
RQL-100

  • Manual blood lancing device, single-use
The Disposable Safety Lancet is intended for capillary blood sampling.
Stat Medical Devices, Inc.
Qwik-Lance Safety Lancet
In Commercial Distribution

  • 40709334761882 ()
  • 00709334761884 ()
RQN-100

  • Manual blood lancing device, single-use
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