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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ACCESS 4806L15 FT SWTCH RMT CNTRL 15' LG
MEDTRONIC, INC.
4806L15
In Commercial Distribution

  • 00681490860765 ()


  • Foot-switch, electrical
SET MULTIPLE PERFUSION CB14017 DLP
MEDTRONIC, INC.
CB14017
In Commercial Distribution

  • 00681490860659 ()


  • Cardioplegia solution administration adaptor
UCS 4.0X32 X873-132 CANN LAG SCR TI
MEDTRONIC SOFAMOR DANEK, INC.
X873-132
In Commercial Distribution

  • 00681490860574 ()

  • Outer Diameter: 4.0 Millimeter
  • Length: 32.0 Millimeter


  • Orthopaedic bone screw (non-sliding)
UCS 4.0X30 X873-130 CANN LAG SCR TI
MEDTRONIC SOFAMOR DANEK, INC.
X873-130
In Commercial Distribution

  • 00681490860567 ()

  • Length: 30.0 Millimeter
  • Outer Diameter: 4.0 Millimeter


  • Orthopaedic bone screw (non-sliding)
UCS 4.0X28 X873-128 CANN LAG SCR TI
MEDTRONIC SOFAMOR DANEK, INC.
X873-128
In Commercial Distribution

  • 00681490860550 ()

  • Outer Diameter: 4.0 Millimeter
  • Length: 28.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
UCS 4.0X26 X873-126 CANN LAG SCR TI
MEDTRONIC SOFAMOR DANEK, INC.
X873-126
In Commercial Distribution

  • 00681490860543 ()

  • Length: 26.0 Millimeter
  • Outer Diameter: 4.0 Millimeter


  • Orthopaedic bone screw (non-sliding)
UCS 4.0X24 X873-124 CANN LAG SCR TI
MEDTRONIC SOFAMOR DANEK, INC.
X873-124
In Commercial Distribution

  • 00681490860536 ()

  • Length: 24.0 Millimeter
  • Outer Diameter: 4.0 Millimeter


  • Orthopaedic bone screw (non-sliding)
DRILL BIT X0101018 SHORT 13MM
MEDTRONIC SOFAMOR DANEK, INC.
X0101018
In Commercial Distribution

  • 00681490860482 ()


  • Bone tap, reusable
4 CH EP ADC BOARD FOR KEYPOINT
Alpine Biomed ApS
9031C5623
Not in Commercial Distribution

  • 00681490853149 ()


  • Electromyograph
INSTRUMENT 8951616 TPRD IMP ADJUSTR 16MM
MEDTRONIC SOFAMOR DANEK, INC.
8951616
In Commercial Distribution

  • 00681490847179 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
INSTRUMENT 8951611 TPRD IMP HLDR 16 26MM
MEDTRONIC SOFAMOR DANEK, INC.
8951611
In Commercial Distribution

  • 00681490847162 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
INSTRUMENT 8951610 TPRD IMP HLDR 16 23MM
MEDTRONIC SOFAMOR DANEK, INC.
8951610
In Commercial Distribution

  • 00681490847148 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
INSTRUMENT 8951609 TPRD IMP HLDR 16 20MM
MEDTRONIC SOFAMOR DANEK, INC.
8951609
In Commercial Distribution

  • 00681490847131 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
INSTRUMENT 8951608 TPRD IMP DRV SLV 16MM
MEDTRONIC SOFAMOR DANEK, INC.
8951608
In Commercial Distribution

  • 00681490847117 ()


  • Orthopaedic implantation sleeve, reusable
INSTRUMENT 8951607 REAMER PLUG 16MM
MEDTRONIC SOFAMOR DANEK, INC.
8951607
In Commercial Distribution

  • 00681490847100 ()


  • Surgical screwdriver, reusable
INSTRUMENT 8951605 16MM ADJUSTABL REAMER
MEDTRONIC SOFAMOR DANEK, INC.
8951605
In Commercial Distribution

  • 00681490847087 ()


  • Orthopaedic broach
No Description
Biomet Orthopedics, LLC
153907
In Commercial Distribution

  • 00880304005471 ()

  • 10MM THICK 75/79 MM
153907

  • Knee arthroplasty wedge
INSTRUMENT 8951603 16 12MM C STYLE DIST
MEDTRONIC SOFAMOR DANEK, INC.
8951603
In Commercial Distribution

  • 00681490847063 ()


  • Orthopaedic surgical distractor, internal
No Description
Biomet Orthopedics, LLC
153910
In Commercial Distribution

  • 00880304005457 ()

  • 10MM THICK 83 MM
153910

  • Knee arthroplasty wedge
CASE 8959162 TAPERED 16MM INS INNER TRAY
MEDTRONIC SOFAMOR DANEK, INC.
8959162
In Commercial Distribution

  • 00681490847049 ()


  • Instrument tray, reusable
CASE 8959161 TAPERED 16MM INST BASE CASE
MEDTRONIC SOFAMOR DANEK, INC.
8959161
In Commercial Distribution

  • 00681490847025 ()


  • Instrument tray, reusable
INSTRUMENT 8951815 18 14MM SGL BRL OS DS
MEDTRONIC SOFAMOR DANEK, INC.
8951815
In Commercial Distribution

  • 00681490846974 ()


  • Orthopaedic implantation sleeve, reusable
INSTRUMENT 8951814 18 14MM SGL BARL DIST
MEDTRONIC SOFAMOR DANEK, INC.
8951814
In Commercial Distribution

  • 00681490846967 ()


  • Orthopaedic surgical distractor, internal
INSTRUMENT 8951813 18MM SB REAMER PLUG
MEDTRONIC SOFAMOR DANEK, INC.
8951813
In Commercial Distribution

  • 00681490846936 ()


  • Orthopaedic broach
INSTRUMENT 8951615 16 12MM SGL BAR OS DS
MEDTRONIC SOFAMOR DANEK, INC.
8951615
In Commercial Distribution

  • 00681490846929 ()


  • Orthopaedic implantation sleeve, reusable
INSTRUMENT 8951614 16 12MM SGL BARL DIST
MEDTRONIC SOFAMOR DANEK, INC.
8951614
In Commercial Distribution

  • 00681490846912 ()


  • Orthopaedic surgical distractor, internal
INSTRUMENT 8951613 16MM SB REAMER PLUG
MEDTRONIC SOFAMOR DANEK, INC.
8951613
In Commercial Distribution

  • 00681490846905 ()


  • Orthopaedic broach
No Description
Biomet Orthopedics, LLC
11-165224
In Commercial Distribution

  • 00880304005372 ()

  • 50MM OUTER Ø 28MM INNER Ø
11-165224

  • Bipolar femoral head outer component, hemiarthroplasty
No Description
Biomet Orthopedics, LLC
162602
In Commercial Distribution

  • 00880304005365 ()

  • 11 SIZE 135 MM TYPE1 TAPER
162602

  • Uncoated femoral stem prosthesis, one-piece
INSTRUMENT 8951413 14MM SB REAMER PLUG
MEDTRONIC SOFAMOR DANEK, INC.
8951413
In Commercial Distribution

  • 00681490846875 ()


  • Orthopaedic broach
INSTRUMENT 8950013 SGL BAR REAM PLG INSR
MEDTRONIC SOFAMOR DANEK, INC.
8950013
In Commercial Distribution

  • 00681490846868 ()


  • Orthopaedic broach
INSTRUMENT 8950005 SGL BARRL OS DRVR CAP
MEDTRONIC SOFAMOR DANEK, INC.
8950005
In Commercial Distribution

  • 00681490846851 ()


  • Orthopaedic implant driver
CASE 8959012 TAPERED SB INST INNTER TRAY
MEDTRONIC SOFAMOR DANEK, INC.
8959012
In Commercial Distribution

  • 00681490846837 ()


  • Instrument tray, reusable
CASE 8959011 TAPERED SB INST BASE CASE
MEDTRONIC SOFAMOR DANEK, INC.
8959011
In Commercial Distribution

  • 00681490846820 ()


  • Instrument tray, reusable
INSTRUMENT 8951416 TPRD IMP ADJSTR 14MM
MEDTRONIC SOFAMOR DANEK, INC.
8951416
In Commercial Distribution

  • 00681490846516 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
INSTRUMENT 8951410 TPRD IMP HLDR 14 23MM
MEDTRONIC SOFAMOR DANEK, INC.
8951410
In Commercial Distribution

  • 00681490846509 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
INSTRUMENT 8951409 TPRD IMP HLDR 14 20MM
MEDTRONIC SOFAMOR DANEK, INC.
8951409
In Commercial Distribution

  • 00681490846493 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
INSTRUMENT 8951408 TPRD IMP DRV SLV 14MM
MEDTRONIC SOFAMOR DANEK, INC.
8951408
In Commercial Distribution

  • 00681490846486 ()


  • Orthopaedic implantation sleeve, reusable
No Description
Biomet Orthopedics, LLC
104812
In Commercial Distribution

  • 00880304005334 ()

  • 11 SIZE 250 MM TYPE1 TAPER
104812

  • Press-fit femoral stem prosthesis
No Description
Biomet Orthopedics, LLC
103205
In Commercial Distribution

  • 00880304005327 ()

  • 11 SIZE 142 MM TYPE1 TAPER
103205

  • Coated hip femur prosthesis, modular
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