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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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GALAXY FIXATION SYSTEM - 18054242518969

GALAXY TL-HEX CONNECTING POST L100MM D12MM STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18054242518969 ()

  • Length: 100 Millimeter
  • Outer Diameter: 12 Millimeter
99-93032

  • External orthopaedic fixation system, reusable

GALAXY FIXATION SYSTEM - 18054242518945

GALAXY TL-HEX CONNECTING POST L50MM D12MM STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18054242518945 ()

  • Length: 50 Millimeter
  • Outer Diameter: 12 Millimeter
99-93031

  • External orthopaedic fixation system, reusable

Procallus Fixator - 18032568863277

RADIOLUCENT ANKLE CLAMP KIT STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568863277 ()
99-90646

  • External orthopaedic fixation system, reusable

Cutter Driver - 00763000918965

ATHERECTOMY FG02550 CUTTERDRIVER UNI
MEDTRONIC, INC.
FG02550
In Commercial Distribution

  • 00763000918965 ()


  • Mechanical atherectomy system catheter, peripheral

HawkOne™ - 00763000835392

ATHERECTOMY H1-14550 CUTTER DRIVER UNI
MEDTRONIC, INC.
H1-14550
In Commercial Distribution

  • 00763000835392 ()


  • Mechanical atherectomy system catheter, peripheral

PRECICE® Bone Transport System - 00887517014306

Precice Retention Plug and Driver, 10mm
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
BT10-RMV01
In Commercial Distribution

  • 00887517014306 ()
BT10-RMV01

  • Orthopaedic implant-instrument extension adaptor, single-use

PRECICE® Bone Transport System - 00887517013996

Precice Retention Plug and Driver, 11.5mm
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
BT115-RMV01
In Commercial Distribution

  • 00887517013996 ()
BT115-RMV01

  • Orthopaedic implant-instrument extension adaptor, single-use

PRECICE® Bone Transport System - 00887517013989

Precice Retention Plug and Driver, 13mm
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
BT13-RMV01
In Commercial Distribution

  • 00887517013989 ()
BT13-RMV01

  • Orthopaedic implant-instrument extension adaptor, single-use

Precice® Instrument - 00887517011015

PRECICE Drill Bit, 3.5mm Cann Calibr AO
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
CBIT-3.5
In Commercial Distribution

  • 00887517011015 ()

  • Tool/Instrument
CBIT-3.5

  • Cannulated surgical drill bit, single-use

4D and TEE Driver Module Board - 06944904099583

No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-042870-00
In Commercial Distribution

  • 06944904099583 ()


  • General-purpose ultrasound imaging system
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