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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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4D and TEE Driver Module Board - 06944904089713

No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-024451-00
In Commercial Distribution

  • 06944904089713 ()


  • General-purpose ultrasound imaging system

4D and TEE Driver Module Kit - 06944904033327

No Description
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
115-007239-00
In Commercial Distribution

  • 06944904033327 ()


  • General-purpose ultrasound imaging system

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

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

MINI-FIXATION SYSTEMS - 18052469476086

CALCFIX PLUS CALCANEAL FIXATOR STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18052469476086 ()
99-M146

  • External orthopaedic fixation system, reusable

GALAXY FIXATION GEMINI - 18053340348775

GALAXY FIXATION GEMINI MULTIPIN CLAMP STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18053340348775 ()
99-94020

  • External orthopaedic fixation system, reusable

GALAXY FIXATION GEMINI - 18053340348751

GALAXY FIXATION GEMINI DOUBLE MULTIPIN CLAMP MEDIUM STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18053340348751 ()
99-94140

  • External orthopaedic fixation system, reusable

GALAXY FIXATION GEMINI - 18053340348744

GALAXY FIXATION GEMINI DOUBLE MULTIPIN CLAMP STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18053340348744 ()
99-94040

  • External orthopaedic fixation system, reusable
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