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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
Owlet Baby Care, Inc.
OSS 3.0-M1
In Commercial Distribution

  • 00810099090031 ()


  • Multiple vital physiological parameter monitoring system, home-use
No Description
Owlet Baby Care, Inc.
OBL 3.0-M1
In Commercial Distribution

  • 00810099090024 ()


  • Multiple vital physiological parameter monitoring system, home-use
Navident Procedure Kit - for use with the Navident System (955-ND-ND).
Claronav Inc
955-ND-PRK
In Commercial Distribution

  • 07540209990021 ()


  • Surgical planning/navigation-enhancement system
Navident Surgical Navigation System
Claronav Inc
955-ND-ND
In Commercial Distribution

  • 07540209990014 ()


  • Surgical planning/navigation-enhancement system
Handpiece Tracker (HPT)
Claronav Inc
955-ND-HPTG-000
In Commercial Distribution

  • 07540209955952 ()
955-ND-HPTG-000

  • Surgical planning/navigation-enhancement system
Calibrator
Claronav Inc
950-ND-CAL
In Commercial Distribution

  • 07540209955938 ()
950-ND-CAL

  • Surgical planning/navigation-enhancement system
NaviTray
Claronav Inc
955-ND-NTRY
In Commercial Distribution

  • 07540209955921 ()
955-ND-NTRY

  • Surgical planning/navigation-enhancement system
Jaw Tracker T (JTT43)
Claronav Inc
955-ND-JTTB-001
In Commercial Distribution

  • 07540209955914 ()
955-ND-JTTB-001

  • Surgical planning/navigation-enhancement system
JawTracker T (JTT42)
Claronav Inc
955-ND-JTTC-001
In Commercial Distribution

  • 07540209955907 ()
955-ND-JTTC-001

  • Surgical planning/navigation-enhancement system
Jaw Tracker T (JTT41)
Claronav Inc
955-ND-JTTA-001
In Commercial Distribution

  • 07540209955891 ()
955-ND-JTTA-001

  • Surgical planning/navigation-enhancement system
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