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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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N/A - 00643169359086

DEROTATOR X0413040 4.75 APICAL
MEDTRONIC SOFAMOR DANEK, INC.
X0413040
In Commercial Distribution

  • 00643169359086 ()


  • Orthopaedic counter-torque/rod-pushing instrument

Medtronic Reusable Instruments - 00643169359024

TAMP 9010000412 BONE
MEDTRONIC SOFAMOR DANEK, INC.
9010000412
In Commercial Distribution

  • 00643169359024 ()


  • Surgical tamp, reusable

Gastrolyzer - 05060246860368

Measurement of Hydrogen, Methane and Oxygen levels in the exhaled breath.
BEDFONT SCIENTIFIC LIMITED
GastroCHECK
In Commercial Distribution

  • 05060246860368 ()
GASTROCHECK

  • Ambient gas analyser

N/A - 00643169409194

TRAY X0913045 WAVE LONG DISTRACTOR INSTR
MEDTRONIC SOFAMOR DANEK, INC.
X0913045
In Commercial Distribution

  • 00643169409194 ()


  • Instrument tray, reusable

Medtronic Reusable Instruments - 00643169408647

DISTRACTOR EX0913050
MEDTRONIC SOFAMOR DANEK, INC.
EX0913050
In Commercial Distribution

  • 00643169408647 ()


  • Orthopaedic surgical distractor, internal

Medtronic Reusable Instruments - 00643169408517

TAP 9010000509 12MM
MEDTRONIC SOFAMOR DANEK, INC.
9010000509
In Commercial Distribution

  • 00643169408517 ()


  • Bone tap, reusable

Medtronic Reusable Instruments - 00643169408500

DRILL 9010000508 8.6MM
MEDTRONIC SOFAMOR DANEK, INC.
9010000508
In Commercial Distribution

  • 00643169408500 ()


  • Fluted surgical drill bit, reusable

Medtronic Reusable Instruments - 00643169402416

DEPTH STOP 9010000507 HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
9010000507
In Commercial Distribution

  • 00643169402416 ()


  • Surgical drill guide, reusable

Clydesdale™ Spinal System - 00643169373273

TRAY X06131016 CLYDESDALE TRIAL TRAY
MEDTRONIC SOFAMOR DANEK, INC.
X06131016
In Commercial Distribution

  • 00643169373273 ()


  • Instrument tray, reusable

Cusco Specula Insulated with Smoke Tube Large - 05060212052223

No Description
DTR MEDICAL LIMITED
CSI200L
In Commercial Distribution

  • 05060212057624 ()
  • 05060212052223 ()


  • Vaginal speculum, single-use
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