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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 - 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
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