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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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No Description
Biomet Orthopedics, LLC
145173
In Commercial Distribution

  • 00880304003972 ()

  • 70MM
145173

  • Uncoated knee femur prosthesis, metallic
DISTRACTOR PIN W/ FLAT, 12MM
MEDTRONIC SOFAMOR DANEK, INC.
X0800022
In Commercial Distribution

  • 00681490521352 ()


  • Orthopaedic surgical distractor, internal
No Description
Biomet Orthopedics, LLC
113143
In Commercial Distribution

  • 00880304003958 ()

  • STANDARD HEIGHT
113143

  • Bipolar partial shoulder prosthesis
No Description
Biomet Orthopedics, LLC
141658
In Commercial Distribution

  • 00880304003941 ()

  • 18 MM 120 MM
141658

  • Knee femur stem prosthesis
No Description
Biomet Orthopedics, LLC
114068
In Commercial Distribution

  • 00880304003934 ()

  • 8 MM
114068

  • Coated shoulder humeral stem prosthesis
No Description
Biomet Orthopedics, LLC
114090
In Commercial Distribution

  • 00880304003927 ()

  • 6.5 MM 125MM LONG
114090

  • Uncoated shoulder humeral stem prosthesis
No Description
Biomet Orthopedics, LLC
114092
In Commercial Distribution

  • 00880304003910 ()

  • 9.5 MM 125MM LONG
114092

  • Uncoated shoulder humeral stem prosthesis
No Description
Biomet Orthopedics, LLC
141652
In Commercial Distribution

  • 00880304003903 ()

  • 12 MM 120 MM
141652

  • Knee femur stem prosthesis
CASE 1860511 PREMIER INS TRAY LOWER
MEDTRONIC SOFAMOR DANEK, INC.
1860511
In Commercial Distribution

  • 00681490519380 ()


  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
145113
In Commercial Distribution

  • 00880304003880 ()

  • 70MM
145113

  • Uncoated knee femur prosthesis, metallic
No Description
Biomet Orthopedics, LLC
145114
In Commercial Distribution

  • 00880304003873 ()

  • 75MM
145114

  • Uncoated knee femur prosthesis, metallic
CASE 1860508 PREMIER SCREW TRAY LID
MEDTRONIC SOFAMOR DANEK, INC.
1860508
In Commercial Distribution

  • 00681490519359 ()


  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
114816
In Commercial Distribution

  • 00880304003859 ()

  • 3 MM 115MM LENGTH
114816

  • Metal-backed elbow ulna prosthesis
CASE 1860505 PREMIER PLATE TRAY UPPER
MEDTRONIC SOFAMOR DANEK, INC.
1860505
In Commercial Distribution

  • 00681490519328 ()


  • Instrument tray, reusable
CASE 1860503 PREMIER SCREW TRAY MODULE
MEDTRONIC SOFAMOR DANEK, INC.
1860503
In Commercial Distribution

  • 00681490519304 ()


  • Instrument tray, reusable
No Description
Biomet Orthopedics, LLC
108152
In Commercial Distribution

  • 00880304003804 ()

  • 55B SIZE TYPE1 TAPER
108152

  • Coated femoral stem prosthesis, modular
ACCESSORY 3550-16 ANCHOR,BUMPY,DOMESTIC
MEDTRONIC, INC.
3550-16
Not in Commercial Distribution

  • 00681490518031 ()


  • Neurosurgical procedure kit, non-medicated, single-use
INSTRUMENT R30514 HMS PLUS RECON
MEDTRONIC, INC.
R30514
In Commercial Distribution

  • 00681490512084 ()


  • Coagulation timer IVD
4 CH. AMP.BOX/ARM, KEYPOINT
Alpine Biomed ApS
9031C0311
Not in Commercial Distribution

  • 00681490508865 ()


  • Electromyograph
SFTWR 9790XLA LEAD PATIENT LONG 9790 TAC
MEDTRONIC, INC.
9790XLA
Not in Commercial Distribution

  • 00681490501880 ()


  • Cardiac pulse generator reader, home-use
GRASPER 907-500 TANGENT EXT
MEDTRONIC SOFAMOR DANEK, INC.
907-500
In Commercial Distribution

  • 00681490499897 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
INSERTER 907-430 TANGENT FREE HAND
MEDTRONIC SOFAMOR DANEK, INC.
907-430
In Commercial Distribution

  • 00681490499866 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
INNER TRAY 902-920 ANTERIOR 20MM INST
MEDTRONIC SOFAMOR DANEK, INC.
902-920
In Commercial Distribution

  • 00681490499842 ()


  • Instrument tray, reusable
INSTRUMENT 901-410 10MM STARTER DISTRCTR
MEDTRONIC SOFAMOR DANEK, INC.
901-410
In Commercial Distribution

  • 00681490499781 ()


  • Orthopaedic surgical distractor, internal
CASE 897-900 ENDO RING BASE
MEDTRONIC SOFAMOR DANEK, INC.
897-900
In Commercial Distribution

  • 00681490499774 ()


  • Instrument tray, reusable
INSTRUMENT 897-410 RTRCTR BLD 18MMX170MM
MEDTRONIC SOFAMOR DANEK, INC.
897-410
In Commercial Distribution

  • 00681490499750 ()


  • Self-retaining surgical retractor, reusable
BLADE 897-400 RETRACTOR 18MMX120MM
MEDTRONIC SOFAMOR DANEK, INC.
897-400
In Commercial Distribution

  • 00681490499743 ()


  • Self-retaining surgical retractor, reusable
SCREW 876-810 VA SELF TAPPING 4.0X10MM
MEDTRONIC SOFAMOR DANEK, INC.
876-810
In Commercial Distribution

  • 00681490499675 ()

  • Length: 10.0 Millimeter
  • Outer Diameter: 4.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
SCREW 876-710 FA SELF TAPPING 4.0X10MM
MEDTRONIC SOFAMOR DANEK, INC.
876-710
In Commercial Distribution

  • 00681490499668 ()

  • Length: 5.0 Millimeter
  • Outer Diameter: 4.0 Millimeter


  • Spinal bone screw, non-bioabsorbable
SCREW 837-760 TSR3D 7.5X60MM TI
MEDTRONIC SOFAMOR DANEK, INC.
837-760
In Commercial Distribution

  • 00681490499521 ()

  • Length: 60.0 Millimeter
  • Outer Diameter: 7.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
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