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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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Medtronic Reusable Instruments - 00681490847100

INSTRUMENT 8951607 REAMER PLUG 16MM
MEDTRONIC SOFAMOR DANEK, INC.
8951607
In Commercial Distribution

  • 00681490847100 ()


  • Surgical screwdriver, reusable

Medtronic Reusable Instruments - 00681490847087

INSTRUMENT 8951605 16MM ADJUSTABL REAMER
MEDTRONIC SOFAMOR DANEK, INC.
8951605
In Commercial Distribution

  • 00681490847087 ()


  • Orthopaedic broach

FINN KNEE SYSTEM - 00880304005471

No Description
Biomet Orthopedics, LLC
153907
In Commercial Distribution

  • 00880304005471 ()

  • 10MM THICK 75/79 MM
153907

  • Knee arthroplasty wedge

N/A - 00681490847063

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

  • 00681490847063 ()


  • Orthopaedic surgical distractor, internal

FINN KNEE SYSTEM - 00880304005457

No Description
Biomet Orthopedics, LLC
153910
In Commercial Distribution

  • 00880304005457 ()

  • 10MM THICK 83 MM
153910

  • Knee arthroplasty wedge

Medtronic Reusable Instruments - 00681490847049

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

  • 00681490847049 ()


  • Instrument tray, reusable

N/A - 00681490847025

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

  • 00681490847025 ()


  • Instrument tray, reusable

Medtronic Reusable Instruments - 00681490846974

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

  • 00681490846974 ()


  • Orthopaedic implantation sleeve, reusable

N/A - 00681490846967

INSTRUMENT 8951814 18 14MM SGL BARL DIST
MEDTRONIC SOFAMOR DANEK, INC.
8951814
In Commercial Distribution

  • 00681490846967 ()


  • Orthopaedic surgical distractor, internal

Medtronic Reusable Instruments - 00681490846936

INSTRUMENT 8951813 18MM SB REAMER PLUG
MEDTRONIC SOFAMOR DANEK, INC.
8951813
In Commercial Distribution

  • 00681490846936 ()


  • Orthopaedic broach

Medtronic Reusable Instruments - 00681490846929

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

  • 00681490846929 ()


  • Orthopaedic implantation sleeve, reusable

N/A - 00681490846912

INSTRUMENT 8951614 16 12MM SGL BARL DIST
MEDTRONIC SOFAMOR DANEK, INC.
8951614
In Commercial Distribution

  • 00681490846912 ()


  • Orthopaedic surgical distractor, internal

Medtronic Reusable Instruments - 00681490846905

INSTRUMENT 8951613 16MM SB REAMER PLUG
MEDTRONIC SOFAMOR DANEK, INC.
8951613
In Commercial Distribution

  • 00681490846905 ()


  • Orthopaedic broach

RINGLOC BI-POLAR HIP SYSTEM - 00880304005372

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

ANSWER HIP SYSTEM - 00880304005365

No Description
Biomet Orthopedics, LLC
162602
In Commercial Distribution

  • 00880304005365 ()

  • 11 SIZE 135 MM TYPE1 TAPER
162602

  • Uncoated femoral stem prosthesis, one-piece

Medtronic Reusable Instruments - 00681490846875

INSTRUMENT 8951413 14MM SB REAMER PLUG
MEDTRONIC SOFAMOR DANEK, INC.
8951413
In Commercial Distribution

  • 00681490846875 ()


  • Orthopaedic broach

Medtronic Reusable Instruments - 00681490846868

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

  • 00681490846868 ()


  • Orthopaedic broach

Medtronic Reusable Instruments - 00681490846851

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

  • 00681490846851 ()


  • Orthopaedic implant driver

Medtronic Reusable Instruments - 00681490846837

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

  • 00681490846837 ()


  • Instrument tray, reusable

Medtronic Reusable Instruments - 00681490846820

CASE 8959011 TAPERED SB INST BASE CASE
MEDTRONIC SOFAMOR DANEK, INC.
8959011
In Commercial Distribution

  • 00681490846820 ()


  • Instrument tray, reusable

N/A - 00681490846516

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

  • 00681490846516 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

N/A - 00681490846509

INSTRUMENT 8951410 TPRD IMP HLDR 14 23MM
MEDTRONIC SOFAMOR DANEK, INC.
8951410
In Commercial Distribution

  • 00681490846509 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

N/A - 00681490846493

INSTRUMENT 8951409 TPRD IMP HLDR 14 20MM
MEDTRONIC SOFAMOR DANEK, INC.
8951409
In Commercial Distribution

  • 00681490846493 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

N/A - 00681490846486

INSTRUMENT 8951408 TPRD IMP DRV SLV 14MM
MEDTRONIC SOFAMOR DANEK, INC.
8951408
In Commercial Distribution

  • 00681490846486 ()


  • Orthopaedic implantation sleeve, reusable

MALLORY/HEAD REVISION HIP SYSTEM - 00880304005334

No Description
Biomet Orthopedics, LLC
104812
In Commercial Distribution

  • 00880304005334 ()

  • 11 SIZE 250 MM TYPE1 TAPER
104812

  • Press-fit femoral stem prosthesis

TAPERLOC HIP SYSTEM - 00880304005327

No Description
Biomet Orthopedics, LLC
103205
In Commercial Distribution

  • 00880304005327 ()

  • 11 SIZE 142 MM TYPE1 TAPER
103205

  • Coated hip femur prosthesis, modular

Medtronic Reusable Instruments - 00681490846462

INSTRUMENT 8951405 14MM ADJ REAMER
MEDTRONIC SOFAMOR DANEK, INC.
8951405
In Commercial Distribution

  • 00681490846462 ()


  • Orthopaedic broach

BIOMET KNEE SYSTEM - 00880304005303

No Description
Biomet Orthopedics, LLC
141216
In Commercial Distribution

  • 00880304005303 ()

  • 83 MM
141216

  • Uncoated knee tibia prosthesis, metallic

N/A - 00681490846424

INSTRUMENT 8951402 14 10MM STD STYLE DST
MEDTRONIC SOFAMOR DANEK, INC.
8951402
In Commercial Distribution

  • 00681490846424 ()


  • Orthopaedic surgical distractor, internal

Medtronic Reusable Instruments - 00681490846417

CASE 8959142 TAPERED 14MM INS INTER TRAY
MEDTRONIC SOFAMOR DANEK, INC.
8959142
In Commercial Distribution

  • 00681490846417 ()


  • Instrument tray, reusable

N/A - 00681490846400

CASE 8959141 TAPERED 14MM INST BASE CASE
MEDTRONIC SOFAMOR DANEK, INC.
8959141
In Commercial Distribution

  • 00681490846400 ()


  • Instrument tray, reusable

Medtronic Reusable Instruments - 00681490845854

SMOOTH HEMOSTATIC FORCEPS
MEDTRONIC SOFAMOR DANEK, INC.
X0500032
In Commercial Distribution

  • 00681490845854 ()


  • General internal orthopaedic fixation system implantation kit

Medtronic Reusable Instruments - 00681490844680

SHORT MONO DRILL GUIDE
MEDTRONIC SOFAMOR DANEK, INC.
X1200009
In Commercial Distribution

  • 00681490844680 ()


  • Fluted surgical drill bit, reusable

PYRAMESH® Implant System - 00681490844420

PYRAMESH 14 X 10 X 24MM
MEDTRONIC SOFAMOR DANEK, INC.
9051423
In Commercial Distribution

  • 00681490844420 ()

  • 14mm x 10mm x 24mm


  • Extra-gynaecological surgical mesh, metal

PYRAMESH® Implant System - 00681490844413

PYRAMESH 12 X 10 X 24MM
MEDTRONIC SOFAMOR DANEK, INC.
9051223
In Commercial Distribution

  • 00681490844413 ()

  • 12mm x 10mm x 24mm


  • Extra-gynaecological surgical mesh, metal

PYRAMESH® Implant System - 00681490844406

PYRAMESH 10 X 10 X 24MM
MEDTRONIC SOFAMOR DANEK, INC.
9051023
In Commercial Distribution

  • 00681490844406 ()

  • 10mm x 10mm x 24mm


  • Extra-gynaecological surgical mesh, metal

PYRAMESH® Implant System - 00681490844390

PYRAMESH 8 X 10 X 24MM
MEDTRONIC SOFAMOR DANEK, INC.
9050823
In Commercial Distribution

  • 00681490844390 ()

  • 8mm x 10mm x 24mm


  • Extra-gynaecological surgical mesh, metal

PYRAMESH® Implant System - 00681490844383

MESH 9050020 PYRAMESH 20MM
MEDTRONIC SOFAMOR DANEK, INC.
9050020
In Commercial Distribution

  • 00681490844383 ()

  • 20mm


  • Extra-gynaecological surgical mesh, metal

PYRAMESH® Implant System - 00681490844376

MESH 9050018 PYRAMESH 18MM
MEDTRONIC SOFAMOR DANEK, INC.
9050018
In Commercial Distribution

  • 00681490844376 ()

  • 18mm


  • Extra-gynaecological surgical mesh, metal

PYRAMESH® Implant System - 00681490844369

MESH 9050016 PYRAMESH 16MM
MEDTRONIC SOFAMOR DANEK, INC.
9050016
In Commercial Distribution

  • 00681490844369 ()

  • 16mm


  • Extra-gynaecological surgical mesh, metal
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