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 8572004 COMP PLIERS FOR 4.5MM
MEDTRONIC SOFAMOR DANEK, INC.
8572004
In Commercial Distribution

  • 00681490611107 ()


  • Orthopaedic fixation implant alignment tool
No Description
Biomet Orthopedics, LLC
32-343154
In Commercial Distribution

  • 00880304004726 ()
32-343154

  • Knee tibia prosthesis trial, reusable
CASE 8797022 ZEPHIR SUPERIOR IMPLANT
MEDTRONIC SOFAMOR DANEK, INC.
8797022
In Commercial Distribution

  • 00681490610940 ()


  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
32-343150
In Commercial Distribution

  • 00880304004702 ()
32-343150

  • Knee tibia prosthesis trial, reusable
SFTWR 960-649 LANDMARX NDI UPGRADE
MEDTRONIC NAVIGATION, INC.
960-649
Not in Commercial Distribution

  • 00681490607926 ()


  • Multi-purpose stereotactic surgery system
No Description
Biomet Orthopedics, LLC
32-342200
In Commercial Distribution

  • 00880304004672 ()
32-342200

  • Knee femur prosthesis trial, reusable
FRAME 960361 LANDMARX FESS KIT
MEDTRONIC NAVIGATION, INC.
960361
In Commercial Distribution

  • 00681490603829 ()


  • ENT stereotactic surgery system
No Description
Biomet Orthopedics, LLC
32-340012
In Commercial Distribution

  • 00880304004658 ()
32-340012

  • Knee femur prosthesis trial, reusable
PAPER-ELECTROCARDIOGRAM,RECORDING
PHYSIO-CONTROL, INC.
11240
In Commercial Distribution

  • 00681490595896 ()
11240-000013

  • Patient monitoring system module, printing
No Description
Biomet Orthopedics, LLC
32-340010
In Commercial Distribution

  • 00880304004634 ()
32-340010

  • Knee femur prosthesis trial, reusable
LIFEPATCH ECG ELECT ADULT 4 PER PAK
PHYSIO-CONTROL, INC.
11100
In Commercial Distribution

  • 00681490587235 ()
11100-000002

  • Multifunction cardiac electrode
No Description
Biomet Orthopedics, LLC
32-340030
In Commercial Distribution

  • 00880304004610 ()
32-340030

  • Knee femur prosthesis trial, reusable
No Description
Biomet Orthopedics, LLC
32-340014
In Commercial Distribution

  • 00880304004597 ()
32-340014

  • Knee femur prosthesis trial, reusable
CABLE ASSEMBLY, 3-LEAD ECG, IEC, ROHS
PHYSIO-CONTROL, INC.
11110
Not in Commercial Distribution

  • 00681490579100 ()
11110-000030

  • Electrocardiographic lead set, reusable
No Description
Biomet Orthopedics, LLC
32-340033
In Commercial Distribution

  • 00880304004566 ()
32-340033

  • Knee femur prosthesis trial, reusable
FINAL ASSY-LP500,ENGLISHNO VOICE,3 BUTTON OP
PHYSIO-CONTROL, INC.
99401
Not in Commercial Distribution

  • 00681490577571 ()
99401-000164

  • Non-rechargeable public semi-automated external defibrillator
FINAL ASSY-LP500,ENGLISHVOICE,3 BUTTON OP
PHYSIO-CONTROL, INC.
99401
Not in Commercial Distribution

  • 00681490577557 ()
99401-000153

  • Non-rechargeable public semi-automated external defibrillator
FINAL ASSY-LP500,ENGLISHNO VOICE,2 BUTTON OP
PHYSIO-CONTROL, INC.
99401
Not in Commercial Distribution

  • 00681490577533 ()
99401-000150

  • Non-rechargeable public semi-automated external defibrillator
No Description
Biomet Orthopedics, LLC
32-341220
In Commercial Distribution

  • 00880304004542 ()

  • 59 MM
32-341220

  • Knee femur prosthesis trial, reusable
FINAL ASSY-LP500,ENGLISH, VOICE
PHYSIO-CONTROL, INC.
99401
Not in Commercial Distribution

  • 00681490577472 ()
99401-000130

  • Non-rechargeable public semi-automated external defibrillator
FINAL ASSY-LP500,ENG,NOVOICE
PHYSIO-CONTROL, INC.
99401
Not in Commercial Distribution

  • 00681490577465 ()
99401-000127

  • Non-rechargeable public semi-automated external defibrillator
FINAL ASSY - LP500, ENGLISH,NO VOICE
PHYSIO-CONTROL, INC.
99401
Not in Commercial Distribution

  • 00681490577441 ()
99401-000042

  • Non-rechargeable public semi-automated external defibrillator
ASSY-FINAL,LP500
PHYSIO-CONTROL, INC.
99401
Not in Commercial Distribution

  • 00681490576598 ()
99401-000001

  • Non-rechargeable public semi-automated external defibrillator
ASSY-BATTERY,LITHIUM,4CELL,DSIZE,ENG,FAA
PHYSIO-CONTROL, INC.
11141
Not in Commercial Distribution

  • 00681490576345 ()
11141-000014

  • Primary battery
ASSY-BATTERY,SLA,4 CELL,D-SIZE,ENG
PHYSIO-CONTROL, INC.
11141
Not in Commercial Distribution

  • 00681490576154 ()
11141-000002

  • Portable/mobile rechargeable battery pack
2MM DRILL - TRI TIP 17MM
MEDTRONIC SOFAMOR DANEK, INC.
X8796016
In Commercial Distribution

  • 00681490571784 ()


  • Fluted surgical drill bit, reusable
2MM DRILL - TIR TIP 15MM
MEDTRONIC SOFAMOR DANEK, INC.
X8796014
In Commercial Distribution

  • 00681490571777 ()


  • Fluted surgical drill bit, reusable
4.0 X 13MM TAP W/ SOLID HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
X1100016
In Commercial Distribution

  • 00681490570169 ()


  • Bone tap, reusable
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
CANNULA CB57414 FEM ART 14FR CARMEDA 10L
MEDTRONIC, INC.
CB57414
Not in Commercial Distribution

  • 00681490550406 ()

  • Catheter Gauge: 14.0 French


  • Cardiopulmonary bypass cannula, femoral
TACK X6860405 PLATE HOLDING
MEDTRONIC SOFAMOR DANEK, INC.
X6860405
In Commercial Distribution

  • 00681490547895 ()


  • General internal orthopaedic fixation system implantation kit
ADAPTER 9150007 CYLINDRICAL CAGE 24MM
MEDTRONIC SOFAMOR DANEK, INC.
9150007
Not in Commercial Distribution

  • 00681490542722 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
ADAPTER 9150006 CYLINDRICAL CAGE 22MM
MEDTRONIC SOFAMOR DANEK, INC.
9150006
Not in Commercial Distribution

  • 00681490542715 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
ADAPTER 9150005 CYLINDRICAL CAGE 20MM
MEDTRONIC SOFAMOR DANEK, INC.
9150005
Not in Commercial Distribution

  • 00681490542708 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
ADAPTER 9150004 CYLINDRICAL CAGE 18MM
MEDTRONIC SOFAMOR DANEK, INC.
9150004
Not in Commercial Distribution

  • 00681490542692 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
ADAPTER 9150001 CYLINDRICAL CAGE 12MM
MEDTRONIC SOFAMOR DANEK, INC.
9150001
Not in Commercial Distribution

  • 00681490542654 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
SLEEVE 9150029 ADAPTER RETENTION
MEDTRONIC SOFAMOR DANEK, INC.
9150029
In Commercial Distribution

  • 00681490542630 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
Biomet Orthopedics, LLC
32-345115
In Commercial Distribution

  • 00880304004481 ()
32-345115

  • Knee femur prosthesis trial, reusable
CAGE ADAPTER INNER TRAY
MEDTRONIC SOFAMOR DANEK, INC.
9150127
In Commercial Distribution

  • 00681490542616 ()


  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
32-345111
In Commercial Distribution

  • 00880304004467 ()
32-345111

  • Knee femur prosthesis trial, reusable
REMOVER 9150075 CYLINDRICAL THRDED CAGE
MEDTRONIC SOFAMOR DANEK, INC.
9150075
Not in Commercial Distribution

  • 00681490542449 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
Biomet Orthopedics, LLC
32-345135
In Commercial Distribution

  • 00880304004443 ()
32-345135

  • Knee femur prosthesis trial, reusable
HANDLE 9150046 TREPHINE DRIVER PEAR
MEDTRONIC SOFAMOR DANEK, INC.
9150046
In Commercial Distribution

  • 00681490542425 ()


  • Surgical instrument handle, non-torque-limiting
No Description
Biomet Orthopedics, LLC
32-345132
In Commercial Distribution

  • 00880304004429 ()
32-345132

  • Knee femur prosthesis trial, reusable
TREPHINE INNER TRAY
MEDTRONIC SOFAMOR DANEK, INC.
9150125
In Commercial Distribution

  • 00681490542401 ()


  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
32-345131
In Commercial Distribution

  • 00880304004405 ()
32-345131

  • Knee femur prosthesis trial, reusable
CURRETTE 9150054 6 X 11MM
MEDTRONIC SOFAMOR DANEK, INC.
9150054
Not in Commercial Distribution

  • 00681490542371 ()


  • Neurosurgical curette, single-use
No Description
Biomet Orthopedics, LLC
32-347307
In Commercial Distribution

  • 00880304004382 ()
32-347307

  • Bone punch, reusable
SCRAPER 9150057 SIDE LARGE
MEDTRONIC SOFAMOR DANEK, INC.
9150057
In Commercial Distribution

  • 00681490542319 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
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