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 X0315023 MAS 5.5MM
MEDTRONIC SOFAMOR DANEK, INC.
X0315023
In Commercial Distribution

  • 00643169624283 ()


  • Surgical screwdriver, reusable
DRIVER 25100401 POWEREASE
MEDTRONIC SOFAMOR DANEK, INC.
25100401
In Commercial Distribution

  • 00643169623996 ()


  • Surgical screwdriver, reusable
DRIVER NAV6640007 5.5/6.0 BALLST PRC NAV
MEDTRONIC SOFAMOR DANEK, INC.
NAV6640007
In Commercial Distribution

  • 00643169623873 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
FLEXMESH 8002233-6 2.2 LARGE RIGID
MEDTRONIC PS MEDICAL, INC.
8002233-6
In Commercial Distribution

  • 00643169620766 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
FLEXMESH 8001533-6 1.5 LARGE RIGID
MEDTRONIC PS MEDICAL, INC.
8001533-6
In Commercial Distribution

  • 00643169620759 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
FLEXMESH 8001531-6 148X148MM 0.6MM CP1
MEDTRONIC PS MEDICAL, INC.
8001531-6
In Commercial Distribution

  • 00643169620742 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
FLEXMESH 8001523-6 1.5 MEDIUM RIGID
MEDTRONIC PS MEDICAL, INC.
8001523-6
In Commercial Distribution

  • 00643169620735 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
FLEXMESH 8001521-6 1.5 MEDIUM STANDARD
MEDTRONIC PS MEDICAL, INC.
8001521-6
In Commercial Distribution

  • 00643169620728 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
FLEXMESH 8001521-3 1.5 MEDIUM THIN
MEDTRONIC PS MEDICAL, INC.
8001521-3
In Commercial Distribution

  • 00643169620711 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
FLEXMESH 8001511-6 1.5 SML STANDARD
MEDTRONIC PS MEDICAL, INC.
8001511-6
In Commercial Distribution

  • 00643169620704 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
FLEXMESH 8001511-3 1.5 SML THIN
MEDTRONIC PS MEDICAL, INC.
8001511-3
In Commercial Distribution

  • 00643169620698 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
STRAP 241-02 FLUSHMESH 2H X 121MM
MEDTRONIC PS MEDICAL, INC.
241-02
In Commercial Distribution

  • 00643169620681 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PANEL 235 128MM X 79MM X .025
MEDTRONIC PS MEDICAL, INC.
235
In Commercial Distribution

  • 00643169620674 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PANEL 090 CRANIAL 152MM X 152MM
MEDTRONIC PS MEDICAL, INC.
090
In Commercial Distribution

  • 00643169620667 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PANEL 016-200 CRANIAL MESH 200 X 200MM
MEDTRONIC PS MEDICAL, INC.
016-200
In Commercial Distribution

  • 00643169620650 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PANEL 016-152 CRANIAL MESH 152 X 152MM
MEDTRONIC PS MEDICAL, INC.
016-152
In Commercial Distribution

  • 00643169620643 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PANEL 016-128 CRANIAL MESH 128 X 79MM
MEDTRONIC PS MEDICAL, INC.
016-128
In Commercial Distribution

  • 00643169620636 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PANEL 016-120 CRANIAL MESH 120 X 120MM
MEDTRONIC PS MEDICAL, INC.
016-120
In Commercial Distribution

  • 00643169620629 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PANEL 016-100 CRANIAL MESH 100 X 100MM
MEDTRONIC PS MEDICAL, INC.
016-100
In Commercial Distribution

  • 00643169620612 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PLATE 015-276 OHATA QUADSTAR BH 10MM OD
MEDTRONIC PS MEDICAL, INC.
015-276
In Commercial Distribution

  • 00643169620605 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PLATE 015-275 OHATA QUADSTAR BH 8.4MM OD
MEDTRONIC PS MEDICAL, INC.
015-275
In Commercial Distribution

  • 00643169620599 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PLATE 015-273 OHATA KERF COVER
MEDTRONIC PS MEDICAL, INC.
015-273
In Commercial Distribution

  • 00643169620582 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
TRISTAR 015-270 OHATA BURR 8.4MM OD
MEDTRONIC PS MEDICAL, INC.
015-270
In Commercial Distribution

  • 00643169620575 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
BLADE 015-262-18 FAN BURR HOLE 18MM DIA
MEDTRONIC PS MEDICAL, INC.
015-262-18
In Commercial Distribution

  • 00643169620568 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
BLADE 015-262-14 FAN BURR HOLE 14MM DIA
MEDTRONIC PS MEDICAL, INC.
015-262-14
In Commercial Distribution

  • 00643169620551 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
BLADE 015-262-11 FAN BURR HOLE 11MM DIA
MEDTRONIC PS MEDICAL, INC.
015-262-11
In Commercial Distribution

  • 00643169620544 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
MESH 015-260-18 BURR HOLE 18MM DIA
MEDTRONIC PS MEDICAL, INC.
015-260-18
In Commercial Distribution

  • 00643169620537 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
MESH 015-260-14 BURR HOLE 14MM DIA
MEDTRONIC PS MEDICAL, INC.
015-260-14
In Commercial Distribution

  • 00643169620520 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
MESH 015-260-11 BURR HOLE 11MM DIAMETER
MEDTRONIC PS MEDICAL, INC.
015-260-11
In Commercial Distribution

  • 00643169620513 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PLATE 015-258 SMALL RECTANGLE
MEDTRONIC PS MEDICAL, INC.
015-258
In Commercial Distribution

  • 00643169620506 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PLATE 015-257-C SQUARE SMALL RIGID
MEDTRONIC PS MEDICAL, INC.
015-257-C
In Commercial Distribution

  • 00643169620490 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PLATE 015-257 SQUARE SMALL
MEDTRONIC PS MEDICAL, INC.
015-257
In Commercial Distribution

  • 00643169620483 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PLATE 015-255 SMALL X
MEDTRONIC PS MEDICAL, INC.
015-255
In Commercial Distribution

  • 00643169620476 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PLATE 015-247 STRAIGHT 2H X 2H 5MM
MEDTRONIC PS MEDICAL, INC.
015-247
In Commercial Distribution

  • 00643169620469 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PLATE 015-246 STRAIGHT 2H X 2H 2.5MM
MEDTRONIC PS MEDICAL, INC.
015-246
In Commercial Distribution

  • 00643169620452 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
DRIVER X0116073 PLATE HOLDING PIN
MEDTRONIC SOFAMOR DANEK, INC.
X0116073
In Commercial Distribution

  • 00643169731530 ()


  • General internal orthopaedic fixation system implantation kit
DRIVER EX0116074 NUT
MEDTRONIC SOFAMOR DANEK, INC.
EX0116074
In Commercial Distribution

  • 00643169731462 ()


  • General internal orthopaedic fixation system implantation kit
SCREWDRIVER NAV3606195 NAVIGATD THREADED
MEDTRONIC SOFAMOR DANEK, INC.
NAV3606195
In Commercial Distribution

  • 00643169725461 ()


  • Surgical screwdriver, reusable
DRIVER EX0116014 T25 RETAINING TWIST
MEDTRONIC SOFAMOR DANEK, INC.
EX0116014
In Commercial Distribution

  • 00643169723351 ()


  • Surgical screwdriver, reusable
SLEEVE EX1015066 SCREW DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
EX1015066
In Commercial Distribution

  • 00643169722200 ()


  • Orthopaedic implantation sleeve, reusable
STARTER 5580135 SETSCREW T27
MEDTRONIC SOFAMOR DANEK, INC.
5580135
In Commercial Distribution

  • 00643169714731 ()


  • Surgical screwdriver, reusable
DRIVER 4360420 20/25MM EXPANSION
MEDTRONIC SOFAMOR DANEK, INC.
4360420
In Commercial Distribution

  • 00643169631359 ()


  • Surgical screwdriver, reusable
DRIVER 4360413 13MM EXPANSION
MEDTRONIC SOFAMOR DANEK, INC.
4360413
In Commercial Distribution

  • 00643169631342 ()


  • Surgical screwdriver, reusable
DRIVER 4369225 20/25MM ANGLED EXPANSION
MEDTRONIC SOFAMOR DANEK, INC.
4369225
In Commercial Distribution

  • 00643169631335 ()


  • Surgical screwdriver, reusable
DRIVER 6640007 5.5/6.0 BALLAST PERC
MEDTRONIC SOFAMOR DANEK, INC.
6640007
In Commercial Distribution

  • 00643169623866 ()


  • Surgical screwdriver, reusable
PLATE 015-237 Y 3H X 3H 5MM DOUBLE
MEDTRONIC PS MEDICAL, INC.
015-237
In Commercial Distribution

  • 00643169620445 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PLATE 015-236 Y 3H X 3H 2.5MM DOUBLE
MEDTRONIC PS MEDICAL, INC.
015-236
In Commercial Distribution

  • 00643169620438 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PLATE 015-233 SINGLE Y 3HX3H 2.5MM 1.60W
MEDTRONIC PS MEDICAL, INC.
015-233
In Commercial Distribution

  • 00643169620421 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
PLATE 015-230 SINGLE Y 3HX3H 2.5MM 1.07W
MEDTRONIC PS MEDICAL, INC.
015-230
In Commercial Distribution

  • 00643169620414 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
ISOGRID 015-2050 STANDARD 75MM X 75MM
MEDTRONIC PS MEDICAL, INC.
015-2050
In Commercial Distribution

  • 00643169620407 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
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