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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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INSTRUMENT 8756490 PIN DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
8756490
In Commercial Distribution

  • 00681490520140 ()


  • Orthopaedic implant driver
INSTRUMENT 8756412 DISTRACTOR PIN 12MM
MEDTRONIC SOFAMOR DANEK, INC.
8756412
In Commercial Distribution

  • 00681490520089 ()


  • Orthopaedic surgical distractor, internal
  • Surgical screwdriver, reusable
M8 INST 8680052 M8 MULTI AXIAL SCRWDR
MEDTRONIC SOFAMOR DANEK, INC.
8680052
In Commercial Distribution

  • 00681490520010 ()


  • Surgical screwdriver, reusable
OsteoMed Singe use Sterile Power Driver, 1x, for use with WayPoint Combo Driver bit
FHC, INC.
68-OM-SD-00365
In Commercial Distribution

  • 00873263003657 ()
68-OM-SD

  • Neurological stereotactic surgery system
OsteoMed Manual Driver Handle
FHC, INC.
66-WP-DH-00323
In Commercial Distribution

  • 00873263003237 ()
66-WP-DH

  • Neurological stereotactic surgery system
WayPoint Combination Driver Bit with Collar
FHC, INC.
66-WP-CD-01-00320
In Commercial Distribution

  • 00873263003206 ()
66-WP-CD-01

  • Neurological stereotactic surgery system
WayPoint Combination Driver Bit
FHC, INC.
66-WP-CD-00318
In Commercial Distribution

  • 00873263003183 ()
66-WP-CD

  • Neurological stereotactic surgery system
WayPoint Surgical Kit Contains: Anchor Hex Wrench - 66-WP-HW Burr Hole Entry Marker Tool & Bushing 66-MP-EM STar SteriSuite Case 6mm Standoff Wrench - 66-WP-SW WayPoint Driver Handle - 66-WP-DH Combination Driver Bit - 66-WP-CD microTargeting Sterilization Tray - 67-00-1
FHC, INC.
66-WP-MR-00317
Not in Commercial Distribution

  • 00873263001721 ()
  • 00873263003176 ()
66-WP-MR

  • Neurological stereotactic surgery system
LOCKSCREW DRIVER W/MOD HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
X1100015
In Commercial Distribution

  • 00681490570152 ()


  • Orthopaedic implant driver
SCREWDRIVER W/SOLID HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
X1100014
In Commercial Distribution

  • 00681490570145 ()


  • Orthopaedic implant driver
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