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 7350162 ROD BENDER 3.5MM ROD
MEDTRONIC SOFAMOR DANEK, INC.
7350162
In Commercial Distribution

  • 00885074011844 ()


  • Manual orthopaedic bender, reusable
14/12 (ALUM) BRIDWELL TRIAL
MEDTRONIC SOFAMOR DANEK, INC.
X1103087
In Commercial Distribution

  • 00885074007236 ()


  • Surgical implant template, reusable
14/10 (ALUM) BRIDWELL TRIAL
MEDTRONIC SOFAMOR DANEK, INC.
X1103086
In Commercial Distribution

  • 00885074007168 ()


  • Surgical implant template, reusable
12/10 (ALUM) BRIDWELL TRIAL
MEDTRONIC SOFAMOR DANEK, INC.
X1103085
In Commercial Distribution

  • 00885074007151 ()


  • Surgical implant template, reusable
12/8 (ALUM) BRIDWELL TRIAL
MEDTRONIC SOFAMOR DANEK, INC.
X1103084
In Commercial Distribution

  • 00885074007144 ()


  • Surgical implant template, reusable
10/8 (ALUM) BRIDWELL TRIAL
MEDTRONIC SOFAMOR DANEK, INC.
X1103083
In Commercial Distribution

  • 00885074007106 ()


  • Surgical implant template, reusable
8/8 (ALUM) BRIDWELL TRIAL
MEDTRONIC SOFAMOR DANEK, INC.
X1103082
In Commercial Distribution

  • 00885074007052 ()


  • Surgical implant template, reusable
14/12 (PLASTIC) BRIDWELL TRIAL
MEDTRONIC SOFAMOR DANEK, INC.
X1103081
In Commercial Distribution

  • 00885074007045 ()


  • Surgical implant template, reusable
14/10 (PLASTIC) BRIDWELL TRIAL
MEDTRONIC SOFAMOR DANEK, INC.
X1103080
In Commercial Distribution

  • 00885074007038 ()


  • Surgical implant template, reusable
12/10 (PLASTIC) BRIDWELL TRIAL
MEDTRONIC SOFAMOR DANEK, INC.
X1103079
In Commercial Distribution

  • 00885074007014 ()


  • Surgical implant template, reusable
12/8 (PLASTIC) BRIDWELL TRIAL
MEDTRONIC SOFAMOR DANEK, INC.
X1103078
In Commercial Distribution

  • 00885074007007 ()


  • Surgical implant template, reusable
10/8 (PLASTIC) BRIDWELL TRIAL
MEDTRONIC SOFAMOR DANEK, INC.
X1103077
In Commercial Distribution

  • 00885074006994 ()


  • Surgical implant template, reusable
8/8 (PLASTIC) BRIDWELL TRIAL
MEDTRONIC SOFAMOR DANEK, INC.
X1103076
In Commercial Distribution

  • 00885074006802 ()


  • Surgical implant template, reusable
ATL SCR-ST-VA-4.0X20MM
MEDTRONIC SOFAMOR DANEK, INC.
X1203002
In Commercial Distribution

  • 00885074005690 ()


  • Surgical retractor/retraction system blade, reusable
REDUCER X1103500 MAST M8 ROD
MEDTRONIC SOFAMOR DANEK, INC.
X1103500
In Commercial Distribution

  • 00885074004808 ()


  • Orthopaedic rod reducer
REAMER X1103472 HOLLOW 10 MM
MEDTRONIC SOFAMOR DANEK, INC.
X1103472
In Commercial Distribution

  • 00885074003955 ()


  • Orthopaedic broach
PITUITARY 9198420 RONG LONG DOWNBITING
MEDTRONIC SOFAMOR DANEK, INC.
9198420
In Commercial Distribution

  • 00885074237831 ()


  • Orthopaedic joint/limb rongeur
INSTRUMENT 6971366 RASP
MEDTRONIC SOFAMOR DANEK, INC.
6971366
In Commercial Distribution

  • 00885074235202 ()


  • Bone file/rasp, manual, reusable
MICRO DENTAL DISSECTOR
MEDTRONIC SOFAMOR DANEK, INC.
X8750503
In Commercial Distribution

  • 00885074234397 ()


  • Open-surgery dissector
MICRO NERVE HOOK LARGE BLUNT
MEDTRONIC SOFAMOR DANEK, INC.
X8750502
In Commercial Distribution

  • 00885074234380 ()


  • General internal orthopaedic fixation system implantation kit
HOOK X8750501 MICRO NERVE SMALL BLUNT
MEDTRONIC SOFAMOR DANEK, INC.
X8750501
In Commercial Distribution

  • 00885074234366 ()


  • General internal orthopaedic fixation system implantation kit
CURRETTE X8750380 MICRO ANGLED 6-0
MEDTRONIC SOFAMOR DANEK, INC.
X8750380
In Commercial Distribution

  • 00885074234328 ()


  • Bone curette, reusable
CURRETTE X8750373 MICRO STRAIGHT 3-0
MEDTRONIC SOFAMOR DANEK, INC.
X8750373
In Commercial Distribution

  • 00885074234304 ()


  • Bone curette, reusable
4.0MM FLEXIBLE DRILL BIT
MEDTRONIC SOFAMOR DANEK, INC.
X0204028
In Commercial Distribution

  • 00885074223841 ()


  • Fluted surgical drill bit, reusable
INSTRUMENT 7005776 LK NT DR SHFT TRI FLT
MEDTRONIC SOFAMOR DANEK, INC.
7005776
In Commercial Distribution

  • 00885074223292 ()


  • Surgical drill guide, reusable
RETRACTOR 9198421 WIDE NERVE ROOT DR
MEDTRONIC SOFAMOR DANEK, INC.
9198421
In Commercial Distribution

  • 00885074222240 ()


  • Surgical retractor/retraction system blade, reusable
CHISEL 9198414 DR 14MM
MEDTRONIC SOFAMOR DANEK, INC.
9198414
In Commercial Distribution

  • 00885074222226 ()


  • Orthopaedic osteotome
CHISEL 9198412 DR 12MM
MEDTRONIC SOFAMOR DANEK, INC.
9198412
In Commercial Distribution

  • 00885074222219 ()


  • Orthopaedic osteotome
CHISEL 9198410 DR 10MM
MEDTRONIC SOFAMOR DANEK, INC.
9198410
In Commercial Distribution

  • 00885074222196 ()


  • Orthopaedic osteotome
CHISEL 9198408 DR 8MM
MEDTRONIC SOFAMOR DANEK, INC.
9198408
In Commercial Distribution

  • 00885074222172 ()


  • Orthopaedic osteotome
PIN X0304066 DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
X0304066
In Commercial Distribution

  • 00885074210360 ()


  • Surgical drill guide, reusable
DR SET INSTRUMENT TRAY 4
MEDTRONIC SOFAMOR DANEK, INC.
9198454
In Commercial Distribution

  • 00885074209784 ()


  • Instrument tray, reusable
DR SET INSTRUMENT TRAY 3
MEDTRONIC SOFAMOR DANEK, INC.
9198453
In Commercial Distribution

  • 00885074209777 ()


  • Instrument tray, reusable
DR SET INSTRUMENT TRAY 2
MEDTRONIC SOFAMOR DANEK, INC.
9198452
In Commercial Distribution

  • 00885074209760 ()


  • Instrument tray, reusable
DR SET INSTRUMENT TRAY 1
MEDTRONIC SOFAMOR DANEK, INC.
9198451
In Commercial Distribution

  • 00885074209753 ()


  • Instrument tray, reusable
DR SET OUTER CASE
MEDTRONIC SOFAMOR DANEK, INC.
9198450
In Commercial Distribution

  • 00885074209722 ()


  • Instrument tray, reusable
INSTRUMENT 9790921 4 0X11MM TAP
MEDTRONIC SOFAMOR DANEK, INC.
9790921
In Commercial Distribution

  • 00885074205823 ()


  • Bone tap, reusable
TUBE X0804040 MX 20MMX9CM OD CUT 180
MEDTRONIC SOFAMOR DANEK, INC.
X0804040
In Commercial Distribution

  • 00885074205731 ()


  • Bone graft funnel
3.2MM DRILL BIT
MEDTRONIC SOFAMOR DANEK, INC.
X0604014
In Commercial Distribution

  • 00885074205724 ()


  • Surgical drill guide, reusable
2.7MM DRILL BIT
MEDTRONIC SOFAMOR DANEK, INC.
X0604013
In Commercial Distribution

  • 00885074205717 ()


  • Surgical drill guide, reusable
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