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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 Resuable Instruments - 00643169800106

DRIVER EX0616012 SHORTEN T8-T10
MEDTRONIC SOFAMOR DANEK, INC.
EX0616012
In Commercial Distribution

  • 00643169800106 ()


  • Surgical screwdriver, reusable

N/A - 00643169800045

DRIVER X0416007 NUT 4.75 REDUCER
MEDTRONIC SOFAMOR DANEK, INC.
X0416007
In Commercial Distribution

  • 00643169800045 ()


  • Orthopaedic rod reducer

N/A - 00643169800038

REDUCER X0416006 4.75
MEDTRONIC SOFAMOR DANEK, INC.
X0416006
In Commercial Distribution

  • 00643169800038 ()


  • Surgical screwdriver, reusable

N/A - 00643169799950

SCREWDRIVER EX0616081 RETNG BONE 5.5/6.0
MEDTRONIC SOFAMOR DANEK, INC.
EX0616081
In Commercial Distribution

  • 00643169799950 ()


  • Surgical screwdriver, reusable

Medtronic Resuable Instruments - 00643169799660

AWL EX0616054 STRGHT FLEXIBLE-TROCAR TIP
MEDTRONIC SOFAMOR DANEK, INC.
EX0616054
In Commercial Distribution

  • 00643169799660 ()


  • Surgical screwdriver, reusable

N/A - 00643169799585

DRIVER EX0516002 SHORT PLATE HOLDING PIN
MEDTRONIC SOFAMOR DANEK, INC.
EX0516002
In Commercial Distribution

  • 00643169799585 ()


  • Orthopaedic implant driver

N/A - 00643169789326

DRIVER X1215009 TAMPONADE
MEDTRONIC SOFAMOR DANEK, INC.
X1215009
In Commercial Distribution

  • 00643169789326 ()


  • Surgical screwdriver, reusable

Medtronic Reusable Instruments - 00643169785984

REMOVAL BIT X0815014 T27 WITH OBTURATOR
MEDTRONIC SOFAMOR DANEK, INC.
X0815014
In Commercial Distribution

  • 00643169785984 ()


  • Surgical screwdriver, reusable

Medtronic Reusable Instruments - 00643169785960

DRIVER X0714017 6.35MM PROVISIONAL
MEDTRONIC SOFAMOR DANEK, INC.
X0714017
In Commercial Distribution

  • 00643169785960 ()


  • Orthopaedic implant driver

Medtronic Reusable Instruments - 00643169785939

SCREWDRIVER X0714014 FIXED AXIAL
MEDTRONIC SOFAMOR DANEK, INC.
X0714014
In Commercial Distribution

  • 00643169785939 ()


  • Orthopaedic implant driver

Medtronic Reusable Instruments - 00643169785922

SCREWDRIVER X0714013 MULTI AXIAL
MEDTRONIC SOFAMOR DANEK, INC.
X0714013
In Commercial Distribution

  • 00643169785922 ()


  • Orthopaedic implant driver

n/a - 00643169785687

DRIVER 6550031 5.5/6.0 SV NUT DRIVER
MEDTRONIC SOFAMOR DANEK, INC.
6550031
In Commercial Distribution

  • 00643169785687 ()


  • Surgical screwdriver, reusable

n/a - 00643169783652

SCREWDRIVER EX0416052 U JOINT T25
MEDTRONIC SOFAMOR DANEK, INC.
EX0416052
In Commercial Distribution

  • 00643169783652 ()


  • Surgical screwdriver, reusable

OsteoCentric Headless Compression System 2.0mm Hex Driver Shaft Cannulated - 00850015496394

Headless Compression System 2.0mm Hex Driver Shaft Cannulated
Osteocentric Technologies, Inc.
EX01-0033
In Commercial Distribution

  • 00850015496394 ()
EX01-0033

  • Surgical screwdriver, reusable

S-Core™ - 00850017962422

T10 Torque Driver
SUBCHONDRAL SOLUTIONS, INC.
10-4010
In Commercial Distribution

  • 00850017962422 ()
10-4010

  • Orthopaedic bone screw, non-bioabsorbable, sterile

Amplion Care Assurance - 00850016398024

Alert Display Driver (ADD) - Configuration 2 (curved)
AMPLION CLINICAL COMMUNICATIONS, INC.
D-ADD-X-2
Not in Commercial Distribution

  • 00850016398024 ()
D-ADD-X-2

  • Nurse call system

Amplion Care Assurance - 00850016398017

Alert Display Driver (ADD) - Configuration 1
AMPLION CLINICAL COMMUNICATIONS, INC.
D-ADD-X-1
Not in Commercial Distribution

  • 00850016398017 ()
D-ADD-X-1

  • Nurse call system

TRUMATCH - 05420060380761

Midface Reconstruction kit
Materialise NV
SD980.032
In Commercial Distribution

  • 05420060380761 ()
SD980.032

  • Custom-made organ/bone anatomy model/surgical guide kit

TRUMATCH - 05420060380754

Mandible Reconstruction kit
Materialise NV
SD980.031
In Commercial Distribution

  • 05420060380754 ()
SD980.031

  • Custom-made organ/bone anatomy model/surgical guide kit

TRUMATCH - 05420060380747

Titanium 3D Printed Guide, Bone harvesting
Materialise NV
SD980.028
In Commercial Distribution

  • 05420060380747 ()
SD980.028

  • Custom-made orthopaedic/craniofacial surgical guide

SkyOPS - 00850024702493

Inserter, Medial Bunion-Alt Distal (Right)
Sky Surgical, LLC
001-2-11-R
In Commercial Distribution

  • 00850024702493 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

SkyOPS - 00850024702486

Inserter, Medial Bunion-Alt Distal (Left)
Sky Surgical, LLC
001-2-11-L
In Commercial Distribution

  • 00850024702486 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

SkyOPS - 00850024702479

Inserter, Dorsal Bunion (Right)
Sky Surgical, LLC
001-2-10-R
In Commercial Distribution

  • 00850024702479 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

SkyOPS - 00850024702462

Inserter, Dorsal Bunion (Left)
Sky Surgical, LLC
001-2-10-L
In Commercial Distribution

  • 00850024702462 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

SkyOPS - 00850024702448

Screwdriver Bit, T6 Tapered
Sky Surgical, LLC
001-1-07
In Commercial Distribution

  • 00850024702448 ()


  • Surgical screwdriver, reusable

SkyOPS - 00850024702363

Inserter, Medial Bunion (Right)
Sky Surgical, LLC
001-2-04-R
In Commercial Distribution

  • 00850024702363 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

SkyOPS - 00850024702356

Inserter, Hallux Limitus/Dorsal Bunion
Sky Surgical, LLC
001-2-09
In Commercial Distribution

  • 00850024702356 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

SkyOPS - 00850024702349

Inserter, Medial Bunion (Left)
Sky Surgical, LLC
001-2-04-L
In Commercial Distribution

  • 00850024702349 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

Medtronic Resuable Instruments - 00643169713949

SCREWDRIVER X1215024 LNG MAS LOCK SLEEVE
MEDTRONIC SOFAMOR DANEK, INC.
X1215024
In Commercial Distribution

  • 00643169713949 ()


  • Surgical screwdriver, reusable

Medtronic Resuable Instruments - 00643169713666

DRIVER EX1115089 TAPERED T27 243MM
MEDTRONIC SOFAMOR DANEK, INC.
EX1115089
In Commercial Distribution

  • 00643169713666 ()


  • Orthopaedic implant driver

Medtronic Resuable Instruments - 00643169694125

SCREWDRIVER EX0915017 SHAFT
MEDTRONIC SOFAMOR DANEK, INC.
EX0915017
In Commercial Distribution

  • 00643169694125 ()


  • Surgical screwdriver, reusable

NA - 00643169693838

DRIVER NAV2024K SOLERA 4.75 STANDARD MAS
MEDTRONIC SOFAMOR DANEK, INC.
NAV2024K
In Commercial Distribution

  • 00643169693838 ()

  • Outer Diameter: 4.75 Millimeter


  • Surgical screwdriver, reusable

CD HORIZON® Spinal System - 00643169693821

DRIVER NAV2024 SOLERA 4.75 STANDARD MAS
MEDTRONIC SOFAMOR DANEK, INC.
NAV2024
In Commercial Distribution

  • 00643169693821 ()


  • Surgical screwdriver, reusable

Medtronic Resuable Instruments - 00643169693715

PENFIELD X1015037 6.5 PUSH/PULL
MEDTRONIC SOFAMOR DANEK, INC.
X1015037
In Commercial Distribution

  • 00643169693715 ()


  • Surgical screwdriver, reusable

Medtronic Resuable Instruments - 00643169693678

ADAPTER X1015013 INLINE
MEDTRONIC SOFAMOR DANEK, INC.
X1015013
In Commercial Distribution

  • 00643169693678 ()


  • Orthopaedic implant driver

Medtronic Resuable Instruments - 00643169693661

DRIVER X1015012 INLINE
MEDTRONIC SOFAMOR DANEK, INC.
X1015012
In Commercial Distribution

  • 00643169693661 ()


  • Orthopaedic implant driver

CD HORIZON® Fenestrated Screw Set - 00643169679429

DRIVER 7480755T 5.5/6.0 MAS LOCK SLEEVE
MEDTRONIC SOFAMOR DANEK, INC.
7480755T
In Commercial Distribution

  • 00643169679429 ()


  • Orthopaedic implant driver

CD HORIZON® Fenestrated Screw Set - 00643169679405

SHAFT 7480741T ADAPTER DRIVER QC SHAFT
MEDTRONIC SOFAMOR DANEK, INC.
7480741T
In Commercial Distribution

  • 00643169679405 ()


  • Orthopaedic implant driver

N/A - 00643169674592

ADAPTER X0815099 OFFSET
MEDTRONIC SOFAMOR DANEK, INC.
X0815099
In Commercial Distribution

  • 00643169674592 ()


  • Orthopaedic implant driver

Medtronic Resuable Instruments - 00643169674561

DRIVER X0815096 OFFSET
MEDTRONIC SOFAMOR DANEK, INC.
X0815096
In Commercial Distribution

  • 00643169674561 ()


  • Orthopaedic implant driver
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