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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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Quick Connect Ball Joint Awl
Spineup, Inc.
RO0037QBJA
In Commercial Distribution

  • B806RO0037QBJA0 ()
RO0037QBJA

  • Bone awl, reusable
Romero Cervical Screw Driver Shaft Ball Joint Quick Connect - 15mm
Spineup, Inc.
RO0036SDBJ
In Commercial Distribution

  • B806RO0036SDBJ0 ()
RO0036SDBJ

  • Orthopaedic implant driver
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
Romero Lateral Finishing Impactor
Spineup, Inc.
RO0028LFIZ
In Commercial Distribution

  • B806RO0028LFIZ0 ()
RO0028LFIZ

  • Orthopaedic implant impactor, reusable
Romero Finishing Impactor
Spineup, Inc.
RO0027FIZZ
In Commercial Distribution

  • B806RO0027FIZZ0 ()
RO0027FIZZ

  • Orthopaedic implant impactor, reusable
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