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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PROBE EX0312211 SPADE TIP BALL HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
EX0312211
In Commercial Distribution

  • 00643169176355 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
CURETTE EX0312492 8MM RING RIGHT
MEDTRONIC SOFAMOR DANEK, INC.
EX0312492
In Commercial Distribution

  • 00643169176348 ()


  • Bone curette, reusable
CURETTE EX0312491 8MM RING LEFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0312491
In Commercial Distribution

  • 00643169176331 ()


  • Bone curette, reusable
CURETTE EX0312490 STRAIGHT CUP
MEDTRONIC SOFAMOR DANEK, INC.
EX0312490
In Commercial Distribution

  • 00643169176324 ()


  • Bone curette, reusable
TAP EX0412154 7.5MM GOLD
MEDTRONIC SOFAMOR DANEK, INC.
EX0412154
In Commercial Distribution

  • 00643169176317 ()


  • Bone tap, reusable
TAP EX0412153 6.5MM GOLD
MEDTRONIC SOFAMOR DANEK, INC.
EX0412153
In Commercial Distribution

  • 00643169176300 ()


  • Bone tap, reusable
TAP EX0412152 5.5MM GOLD
MEDTRONIC SOFAMOR DANEK, INC.
EX0412152
In Commercial Distribution

  • 00643169176294 ()


  • Bone tap, reusable
TAP EX0412151 4.5MM GOLD
MEDTRONIC SOFAMOR DANEK, INC.
EX0412151
In Commercial Distribution

  • 00643169176287 ()


  • Bone tap, reusable
TAP EX0412150 3.75MM GOLD
MEDTRONIC SOFAMOR DANEK, INC.
EX0412150
In Commercial Distribution

  • 00643169176270 ()


  • Bone tap, reusable
BROACH EX0412212 36MM X 28MM X 20MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0412212
In Commercial Distribution

  • 00643169176263 ()


  • Orthopaedic broach
BROACH EX0412211 36MM X 28MM X 18MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0412211
In Commercial Distribution

  • 00643169176256 ()


  • Orthopaedic broach
BROACH EX0412210 36MM X 28MM X 16MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0412210
In Commercial Distribution

  • 00643169176249 ()


  • Orthopaedic broach
BROACH EX0412209 36MM X 28MM X 14MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0412209
In Commercial Distribution

  • 00643169176232 ()


  • Orthopaedic broach
BROACH EX0412208 36MM X 28MM X 12MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0412208
In Commercial Distribution

  • 00643169176225 ()


  • Orthopaedic broach
BROACH EX0412207 36MM X 28MM X 10MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0412207
In Commercial Distribution

  • 00643169176218 ()


  • Orthopaedic broach
BROACH EX0412206 36MM X 28MM X 8MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0412206
In Commercial Distribution

  • 00643169176201 ()


  • Orthopaedic broach
TAP EX0412137 SHORT 06.5MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0412137
In Commercial Distribution

  • 00643169176195 ()


  • Bone tap, reusable
TAP EX0412136 SHORT 05.5MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0412136
In Commercial Distribution

  • 00643169176188 ()


  • Bone tap, reusable
TAP EX0412135 SHORT 04.5MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0412135
In Commercial Distribution

  • 00643169176171 ()


  • Bone tap, reusable
TAP EX0412134 SHORT 04.0MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0412134
In Commercial Distribution

  • 00643169176164 ()


  • Bone tap, reusable
GUIDE EX0412178 DRILL W TEETH
MEDTRONIC SOFAMOR DANEK, INC.
EX0412178
In Commercial Distribution

  • 00643169175334 ()


  • Surgical drill guide, reusable
TRIAL EX0312098 12 X 26
MEDTRONIC SOFAMOR DANEK, INC.
EX0312098
In Commercial Distribution

  • 00643169174436 ()


  • Surgical implant template, reusable
DILATOR EX0911175 LARGE GROOVED OVAL
MEDTRONIC SOFAMOR DANEK, INC.
EX0911175
In Commercial Distribution

  • 00643169171404 ()


  • Laparoscopic access cannula dilator
SHIM EX1011259 LIP OUT SZ 11
MEDTRONIC SOFAMOR DANEK, INC.
EX1011259
In Commercial Distribution

  • 00643169171398 ()


  • Surgical retraction system, reusable
SHIM EX1011260 LIP OUT SZ 13
MEDTRONIC SOFAMOR DANEK, INC.
EX1011260
In Commercial Distribution

  • 00643169171381 ()


  • Surgical retraction system, reusable
SHIM EX1011261 LIP OUT SZ 15
MEDTRONIC SOFAMOR DANEK, INC.
EX1011261
In Commercial Distribution

  • 00643169171374 ()


  • Surgical retraction system, reusable
SHIM EX1011264 LIP IN SZ 15
MEDTRONIC SOFAMOR DANEK, INC.
EX1011264
In Commercial Distribution

  • 00643169171367 ()


  • Surgical retraction system, reusable
SHIM EX1011262 LIP IN SZ 11
MEDTRONIC SOFAMOR DANEK, INC.
EX1011262
In Commercial Distribution

  • 00643169171350 ()


  • Surgical retraction system, reusable
SHIM EX1011263 LIP IN SZ 13
MEDTRONIC SOFAMOR DANEK, INC.
EX1011263
In Commercial Distribution

  • 00643169171343 ()


  • Surgical retraction system, reusable
DRIVER EX0312489 XL PROVISIONAL
MEDTRONIC SOFAMOR DANEK, INC.
EX0312489
In Commercial Distribution

  • 00643169170537 ()


  • Surgical drill guide, reusable
TAP EX0312063 10.5MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0312063
In Commercial Distribution

  • 00643169170322 ()


  • Bone tap, reusable
TAP EX0312062 9.5MM
MEDTRONIC SOFAMOR DANEK, INC.
EX0312062
In Commercial Distribution

  • 00643169170315 ()


  • Bone tap, reusable
RETRACTOR EX0412060 WIDE NERVE ROOT
MEDTRONIC SOFAMOR DANEK, INC.
EX0412060
In Commercial Distribution

  • 00643169170261 ()


  • Surgical retractor/retraction system blade, reusable
FEELER EX0212748 CURVED
MEDTRONIC SOFAMOR DANEK, INC.
EX0212748
In Commercial Distribution

  • 00643169169678 ()


  • Abdominal/ENT/orthopaedic surgical probe, reusable
PROBE EX0212019 STRAIGHT BALL HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
EX0212019
In Commercial Distribution

  • 00643169169654 ()


  • Surgical instrument handle, non-torque-limiting
TAP EX0212018 6.5MM DIA BLUNT TIP QC
MEDTRONIC SOFAMOR DANEK, INC.
EX0212018
In Commercial Distribution

  • 00643169169647 ()


  • Bone tap, reusable
RETRACTOR EX02121233 MALLEABLE 16MM
MEDTRONIC SOFAMOR DANEK, INC.
EX02121233
In Commercial Distribution

  • 00643169167810 ()


  • Surgical retractor/retraction system blade, reusable
RETRACTOR EX02121232 MALLEABLE 12MM
MEDTRONIC SOFAMOR DANEK, INC.
EX02121232
In Commercial Distribution

  • 00643169167803 ()


  • Surgical retractor/retraction system blade, reusable
RETRACTOR EX02121231 MALLEABLE 8MM
MEDTRONIC SOFAMOR DANEK, INC.
EX02121231
In Commercial Distribution

  • 00643169167797 ()


  • Surgical retractor/retraction system blade, reusable
PIN DRIVER EX0312473 SHORTENED
MEDTRONIC SOFAMOR DANEK, INC.
EX0312473
In Commercial Distribution

  • 00643169184220 ()


  • Surgical drill guide, reusable
COMPRESSORS EX0412067 PARALLEL
MEDTRONIC SOFAMOR DANEK, INC.
EX0412067
In Commercial Distribution

  • 00643169184213 ()


  • Orthopaedic surgical distractor, internal
PITUITARY X0512062 MICRO UPBITING
MEDTRONIC SOFAMOR DANEK, INC.
X0512062
In Commercial Distribution

  • 00643169183193 ()


  • Orthopaedic joint/limb rongeur
PITUITARY X0512061 MICRO
MEDTRONIC SOFAMOR DANEK, INC.
X0512061
In Commercial Distribution

  • 00643169183186 ()


  • Orthopaedic joint/limb rongeur
HOOK X0512060 NERVE
MEDTRONIC SOFAMOR DANEK, INC.
X0512060
In Commercial Distribution

  • 00643169183179 ()


  • Surgical retractor/retraction system blade, reusable
CURETTE X0512059 5.2MM REVERSE
MEDTRONIC SOFAMOR DANEK, INC.
X0512059
In Commercial Distribution

  • 00643169183162 ()


  • Bone curette, reusable
CURETTE X0512057 5.2MM STRAIGHT
MEDTRONIC SOFAMOR DANEK, INC.
X0512057
Not in Commercial Distribution

  • 00643169183148 ()


  • Bone curette, reusable
CURETTE X0512056 3.6MM REVERSE
MEDTRONIC SOFAMOR DANEK, INC.
X0512056
In Commercial Distribution

  • 00643169183131 ()


  • Bone curette, reusable
CURETTE X0512055 3.6MM ANGLED
MEDTRONIC SOFAMOR DANEK, INC.
X0512055
In Commercial Distribution

  • 00643169183124 ()


  • Bone curette, reusable
CURETTE X0512053 1.8MM REVERSE
MEDTRONIC SOFAMOR DANEK, INC.
X0512053
In Commercial Distribution

  • 00643169183100 ()


  • Bone curette, reusable
CURETTE X0512052 1.8MM ANGLED
MEDTRONIC SOFAMOR DANEK, INC.
X0512052
In Commercial Distribution

  • 00643169183094 ()


  • Bone curette, reusable
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