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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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No Description
SHANDON DIAGNOSTICS LIMITED
NX50 CRYOSTAR WITH HEIGHT
In Commercial Distribution

  • 05051663010191 ()


  • Cryostat microtome IVD
No Description
SHANDON DIAGNOSTICS LIMITED
HM 355S With STS
In Commercial Distribution

  • 05051663005258 ()


  • Rotary microtome IVD
No Description
SHANDON DIAGNOSTICS LIMITED
NX70 CRYOSTAR WITH HOMVPD
In Commercial Distribution

  • 05051663003896 ()


  • Cryostat microtome IVD
No Description
SHANDON DIAGNOSTICS LIMITED
NX70 CRYOSTAR WITH HOMVP
In Commercial Distribution

  • 05051663003889 ()


  • Cryostat microtome IVD
Cryostar NX70 Cryostat
SHANDON DIAGNOSTICS LIMITED
NX70 with HOMPD, 220-240V
In Commercial Distribution

  • 05051663003872 ()
957050L

  • Cryostat microtome IVD
Cryostar NX70 Cryostat
SHANDON DIAGNOSTICS LIMITED
NX70 with HOMP, 220-240V
In Commercial Distribution

  • 05051663003865 ()
957040L

  • Cryostat microtome IVD
Assisted Reproduction Microtools (Pipettes)
RESEARCH INSTRUMENTS LIMITED
EZ-Grip with Comfort Rest
In Commercial Distribution

  • 05060170183380 ()
7-72-2802

  • Assisted reproduction microtool
REMstar with Humidifier, International
Respironics, Inc.
REMstar, with Humidifier, INTL
Not in Commercial Distribution

  • 00606959036888 ()
IN171H

  • Heated respiratory humidifier
  • Home CPAP unit
No Description
PROSOMNUS SLEEP TECHNOLOGIES
EVO with Patient Monitoring
In Commercial Distribution

  • 00863039000492 ()


  • Mandible-repositioning sleep-disordered breathing orthosis
Siemens UNITY 3 WITH INSERT
Ws Audiology Usa, Inc.
UNITY 3 WITH INSERT
Not in Commercial Distribution

  • 05711781000749 ()
10824331

  • Audiometric/hearing aid tester
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