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 X0705157 5.5 MAS THMBWHL DRVR
MEDTRONIC SOFAMOR DANEK, INC.
X0705157
In Commercial Distribution

  • 00613994106872 ()


  • Orthopaedic implant driver
INSTRUMENT X1005238 DRILL BIT 2.65X32MM
MEDTRONIC SOFAMOR DANEK, INC.
X1005238
In Commercial Distribution

  • 00613994106292 ()


  • Fluted surgical drill bit, reusable
INSTRUMENT X1005237 DRILL BIT 2.30X23MM
MEDTRONIC SOFAMOR DANEK, INC.
X1005237
In Commercial Distribution

  • 00613994106285 ()


  • Fluted surgical drill bit, reusable
INSTRUMENT X1005236 DRILL BIT 1.95X24MM
MEDTRONIC SOFAMOR DANEK, INC.
X1005236
In Commercial Distribution

  • 00613994106278 ()


  • Fluted surgical drill bit, reusable
INSTRUMENT X1005235 DRILL BIT 1.55X24MM
MEDTRONIC SOFAMOR DANEK, INC.
X1005235
In Commercial Distribution

  • 00613994106261 ()


  • Fluted surgical drill bit, reusable
INSTRUMENT X1005312 WRE GDE 3.50X045D SS
MEDTRONIC SOFAMOR DANEK, INC.
X1005312
In Commercial Distribution

  • 00613994105820 ()


  • Spinal intraoperative positioning pin, single-use
INSTRUMENT X0905355 WRE GDE 3.50X045D SS
MEDTRONIC SOFAMOR DANEK, INC.
X0905355
In Commercial Distribution

  • 00613994105806 ()


  • Spinal intraoperative positioning pin, single-use
INSTRUMENT X0405243 DRL BT 2.8X50MM CAN
MEDTRONIC SOFAMOR DANEK, INC.
X0405243
In Commercial Distribution

  • 00613994105790 ()


  • Fluted surgical drill bit, reusable
INSTRUMENT X0905354 RIGHT HALF TUBE130MM
MEDTRONIC SOFAMOR DANEK, INC.
X0905354
In Commercial Distribution

  • 00613994104533 ()


  • Bone graft funnel
INSTRUMENT X0905352 RIGHT HALF TUBE110MM
MEDTRONIC SOFAMOR DANEK, INC.
X0905352
In Commercial Distribution

  • 00613994104519 ()


  • Bone graft funnel
INSTRUMENT X0905350 LEFT HALF TUBE120MM
MEDTRONIC SOFAMOR DANEK, INC.
X0905350
In Commercial Distribution

  • 00613994104496 ()


  • Bone graft funnel
INSTRUMENT X0905349 LEFT HALF TUBE110MM
MEDTRONIC SOFAMOR DANEK, INC.
X0905349
In Commercial Distribution

  • 00613994104465 ()


  • Bone graft funnel
INSTRUMENT X0805223 RIGHT HALF TUBE100MM
MEDTRONIC SOFAMOR DANEK, INC.
X0805223
In Commercial Distribution

  • 00613994104458 ()


  • Bone graft funnel
INSTRUMENT X0805221 LEFT HALF TUBE 100MM
MEDTRONIC SOFAMOR DANEK, INC.
X0805221
In Commercial Distribution

  • 00613994104434 ()


  • Bone graft funnel
INSTRUMENT X0805220 LEFT HALF TUBE90MM
MEDTRONIC SOFAMOR DANEK, INC.
X0805220
In Commercial Distribution

  • 00613994104427 ()


  • Bone graft funnel
PERC PEEK 1000722 CASE
MEDTRONIC SOFAMOR DANEK, INC.
1000722
In Commercial Distribution

  • 00613994468871 ()


  • Instrument tray, reusable
DRIVER X0408012 MAS SHORT
MEDTRONIC SOFAMOR DANEK, INC.
X0408012
In Commercial Distribution

  • 00613994468192 ()


  • Surgical drill guide, reusable
PROBE X0506248 LUMBAR STRAIGHT
MEDTRONIC SOFAMOR DANEK, INC.
X0506248
In Commercial Distribution

  • 00613994466723 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
COMPRESSOR X0806140 BAR MAST
MEDTRONIC SOFAMOR DANEK, INC.
X0806140
In Commercial Distribution

  • 00613994466716 ()


  • Orthopaedic surgical distractor, internal
DISTRACTOR X0405287 TIP WEDGE 5MM
MEDTRONIC SOFAMOR DANEK, INC.
X0405287
In Commercial Distribution

  • 00613994466532 ()


  • Orthopaedic surgical distractor, internal
DISTRACTOR X0405288 TIP WEDGE 6MM
MEDTRONIC SOFAMOR DANEK, INC.
X0405288
In Commercial Distribution

  • 00613994466525 ()


  • Orthopaedic surgical distractor, internal
STEM X0906070 DISTRACTOR
MEDTRONIC SOFAMOR DANEK, INC.
X0906070
In Commercial Distribution

  • 00613994466471 ()


  • Orthopaedic surgical distractor, internal
DISTRACTOR X1204317 TIP 6MM
MEDTRONIC SOFAMOR DANEK, INC.
X1204317
In Commercial Distribution

  • 00613994466464 ()


  • Orthopaedic surgical distractor, internal
DISTRACTOR X1204318 TIP 7MM
MEDTRONIC SOFAMOR DANEK, INC.
X1204318
In Commercial Distribution

  • 00613994466457 ()


  • Orthopaedic surgical distractor, internal
DISTRACTOR X0906065 TIP COPED 5MM
MEDTRONIC SOFAMOR DANEK, INC.
X0906065
In Commercial Distribution

  • 00613994466440 ()


  • Orthopaedic surgical distractor, internal
DISTRACTOR X0906066 TIP COPED 6MM
MEDTRONIC SOFAMOR DANEK, INC.
X0906066
In Commercial Distribution

  • 00613994466433 ()


  • Orthopaedic surgical distractor, internal
DISTRACTOR X0906067 TIP COPED 7MM
MEDTRONIC SOFAMOR DANEK, INC.
X0906067
In Commercial Distribution

  • 00613994466426 ()


  • Orthopaedic surgical distractor, internal
DISTRACTOR X0906068 TIP COPED 8MM
MEDTRONIC SOFAMOR DANEK, INC.
X0906068
In Commercial Distribution

  • 00613994466419 ()


  • Orthopaedic surgical distractor, internal
DISTRACTOR X0906069 TIP COPED 9MM
MEDTRONIC SOFAMOR DANEK, INC.
X0906069
In Commercial Distribution

  • 00613994466402 ()


  • Orthopaedic surgical distractor, internal
CURETTE X0308078 PULL
MEDTRONIC SOFAMOR DANEK, INC.
X0308078
In Commercial Distribution

  • 00613994463432 ()


  • Bone curette, reusable
COMPRESSOR X0308149 PARALLEL SMALL
MEDTRONIC SOFAMOR DANEK, INC.
X0308149
In Commercial Distribution

  • 00613994455345 ()


  • Orthopaedic surgical distractor, internal
DRIVER X0208221 EXTENDED PIN
MEDTRONIC SOFAMOR DANEK, INC.
X0208221
In Commercial Distribution

  • 00613994447432 ()


  • Orthopaedic implant driver
TUBULAR BENDER X0208227 3.2 - 3.5 ROD
MEDTRONIC SOFAMOR DANEK, INC.
X0208227
In Commercial Distribution

  • 00613994447012 ()


  • Manual orthopaedic bender, reusable
DRIVER 8350517 T25 SET SCRW SWZZLE STICK
MEDTRONIC SOFAMOR DANEK, INC.
8350517
In Commercial Distribution

  • 00613994445148 ()


  • General internal orthopaedic fixation system implantation kit
BLADE X0208220N 220 NRW ENDO SACRAL BEND
MEDTRONIC SOFAMOR DANEK, INC.
X0208220N
In Commercial Distribution

  • 00613994444455 ()


  • Surgical retraction system, reusable
BLADE X0208170L1 170 LF ENDO SACRAL BEND
MEDTRONIC SOFAMOR DANEK, INC.
X0208170L1
In Commercial Distribution

  • 00613994444448 ()


  • Surgical retraction system, reusable
BLADE X0208170R1 170 RT ENDO SACRAL BEND
MEDTRONIC SOFAMOR DANEK, INC.
X0208170R1
In Commercial Distribution

  • 00613994444431 ()


  • Surgical retraction system, reusable
BLADE X0208220L1 220 LF ENDO SACRAL BEND
MEDTRONIC SOFAMOR DANEK, INC.
X0208220L1
In Commercial Distribution

  • 00613994444424 ()


  • Surgical retraction system, reusable
BLADE X0208220R1 220 RT ENDO SACRAL BEND
MEDTRONIC SOFAMOR DANEK, INC.
X0208220R1
In Commercial Distribution

  • 00613994444417 ()


  • Surgical retraction system, reusable
SCREW X1207074 SHORT POST 9.0X40 TI
MEDTRONIC SOFAMOR DANEK, INC.
X1207074
In Commercial Distribution

  • 00613994436245 ()


  • Spinal bone screw, non-bioabsorbable
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