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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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HOLO Hex Driver, Sterile
Surgalign Spine Technologies, Inc.
154000056
In Commercial Distribution

  • 00850028694121 ()


  • Multi-purpose stereotactic surgery system
Inserter, Medial Bunion-Alt Distal (Right)
Sky Surgical, LLC
001-2-11-R
In Commercial Distribution

  • 00850024702493 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Inserter, Medial Bunion-Alt Distal (Left)
Sky Surgical, LLC
001-2-11-L
In Commercial Distribution

  • 00850024702486 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Inserter, Dorsal Bunion (Right)
Sky Surgical, LLC
001-2-10-R
In Commercial Distribution

  • 00850024702479 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Inserter, Dorsal Bunion (Left)
Sky Surgical, LLC
001-2-10-L
In Commercial Distribution

  • 00850024702462 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Screwdriver Bit, T6 Tapered
Sky Surgical, LLC
001-1-07
In Commercial Distribution

  • 00850024702448 ()


  • Surgical screwdriver, reusable
Inserter, Medial Bunion (Right)
Sky Surgical, LLC
001-2-04-R
In Commercial Distribution

  • 00850024702363 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Inserter, Hallux Limitus/Dorsal Bunion
Sky Surgical, LLC
001-2-09
In Commercial Distribution

  • 00850024702356 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Inserter, Medial Bunion (Left)
Sky Surgical, LLC
001-2-04-L
In Commercial Distribution

  • 00850024702349 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
aprevo® Angled Driver
Carlsmed, Inc.
1540
In Commercial Distribution

  • 00810056993030 ()


  • Orthopaedic inorganic implant inserter/extractor, single-use
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