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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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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
DRIVER EX1116062 T-HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
EX1116062
In Commercial Distribution

  • 00643169937987 ()


  • General internal orthopaedic fixation system implantation kit
SCREWDRIVER EX1116022 T8/T10 U-JOINT
MEDTRONIC SOFAMOR DANEK, INC.
EX1116022
In Commercial Distribution

  • 00643169931701 ()


  • Orthopaedic implant driver
ATT MR8 MR8-AD02 DRIVER JACOBS CHK 5/32
MEDTRONIC POWERED SURGICAL SOLUTIONS
MR8-AD02
In Commercial Distribution

  • 00643169912724 ()


  • Burring power tool attachment
INSTRUMENT EX1116116 SCREW REMOVAL T8T10
MEDTRONIC SOFAMOR DANEK, INC.
EX1116116
In Commercial Distribution

  • 00643169949997 ()


  • Surgical screwdriver, reusable
DRIVER X1116057 CANNULATED TAMPONADE
MEDTRONIC SOFAMOR DANEK, INC.
X1116057
In Commercial Distribution

  • 00643169935914 ()


  • General internal orthopaedic fixation system implantation kit
ATT MR8-AD03 MR8 PERF DRIVER 1000RPM
MEDTRONIC POWERED SURGICAL SOLUTIONS
MR8-AD03
In Commercial Distribution

  • 00643169912717 ()


  • Burring power tool attachment
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