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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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Romero Universal Rasp
Spineup, Inc.
RO0035URZZ
In Commercial Distribution

  • B806RO0035URZZ0 ()
RO0035URZZ

  • Bone file/rasp, manual, reusable
Romero Cervical Screw Driver Shaft Ball Joint Quick Connect - 25mm
Spineup, Inc.
RO0034SDBJ
In Commercial Distribution

  • B806RO0034SDBJ0 ()
RO0034SDBJ

  • Orthopaedic implant driver
Romero Introducer Shaft
Spineup, Inc.
RO0033ISZZ
In Commercial Distribution

  • B806RO0033ISZZ0 ()
RO0033ISZZ

  • Orthopaedic inorganic implant inserter/extractor, reusable
Free Hand Introducer for Extended Heights greater than or equal to 10
Spineup, Inc.
RO0032FHIE
In Commercial Distribution

  • B806RO0032FHIE0 ()
RO0032FHIE

  • Orthopaedic inorganic implant inserter/extractor, reusable
Free Hand Introducer for Standard Heights (H < 10)
Spineup, Inc.
RO0031FHIS
In Commercial Distribution

  • B806RO0031FHIS0 ()
RO0031FHIS

  • Orthopaedic inorganic implant inserter/extractor, reusable
Free Hand Introducer With Stop for Standard Heights (H < 10)
Spineup, Inc.
RO0030FHSS
In Commercial Distribution

  • B806RO0030FHSS0 ()
RO0030FHSS

  • Orthopaedic inorganic implant inserter/extractor, reusable
Cervical Drill Revision with Stop L19
Spineup, Inc.
GN0101D219
In Commercial Distribution

  • B806GN0101D2190 ()
GN0101D219

  • Fluted surgical drill bit, reusable
Cervical Drill Revision with Stop L18
Spineup, Inc.
GN0100D218
In Commercial Distribution

  • B806GN0100D2180 ()
GN0100D218

  • Fluted surgical drill bit, reusable
Cervical Drill Revision with Stop L17
Spineup, Inc.
GN0099D217
In Commercial Distribution

  • B806GN0099D2170 ()
GN0099D217

  • Fluted surgical drill bit, reusable
Cervical Drill Revision with Stop L16
Spineup, Inc.
GN0098D216
In Commercial Distribution

  • B806GN0098D2160 ()
GN0098D216

  • Fluted surgical drill bit, reusable
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