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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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Angled Awl
Spineup, Inc.
RO0013AAZZ
In Commercial Distribution

  • B806RO0013AAZZ0 ()
RO0013AAZZ

  • Bone awl, reusable
Fixed Angle Awl
Spineup, Inc.
RO0012FAAZ
In Commercial Distribution

  • B806RO0012FAAZ0 ()
RO0012FAAZ

  • Bone awl, reusable
Awl
Spineup, Inc.
RO0010AZZZ
In Commercial Distribution

  • B806RO0010AZZZ0 ()
RO0010AZZZ

  • Bone awl, reusable
Angled Single Barrel Guide
Spineup, Inc.
RO0009ASBG
In Commercial Distribution

  • B806RO0009ASBG0 ()
RO0009ASBG

  • Surgical drill guide, reusable
Single Barrel Guide
Spineup, Inc.
RO0008SBGZ
In Commercial Distribution

  • B806RO0008SBGZ0 ()
RO0008SBGZ

  • Surgical drill guide, reusable
Romero Large Introducer for Extended Heights (H is greater than or equal to 10)
Spineup, Inc.
RO0006LIEH
In Commercial Distribution

  • B806RO0006LIEH0 ()
RO0006LIEH

  • Orthopaedic inorganic implant inserter/extractor, reusable
Romero Large Introducer for Standard Heights (H is less than 10)
Spineup, Inc.
RO0005LISH
In Commercial Distribution

  • B806RO0005LISH0 ()
RO0005LISH

  • Orthopaedic inorganic implant inserter/extractor, reusable
Narrow Introducer for Extended Heights H is greater than or equal to 10
Spineup, Inc.
RO0004NIEH
In Commercial Distribution

  • B806RO0004NIEH0 ()
RO0004NIEH

  • Orthopaedic inorganic implant inserter/extractor, reusable
Narrow Introducer for Standard Heights is less than or equal to 10
Spineup, Inc.
RO0003NISH
In Commercial Distribution

  • B806RO0003NISH0 ()
RO0003NISH

  • Orthopaedic inorganic implant inserter/extractor, reusable
Romero Lateral Finishing Impactor XL
Spineup, Inc.
RO0002LFIX
In Commercial Distribution

  • B806RO0002LFIX0 ()
RO0002LFIX

  • Orthopaedic implant impactor, reusable
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