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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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Chart Projector HCP-7000 - 08800019600237

chart projector is intended to be used to check eye optometry
Huvitz Co., Ltd.
HCP-7000
In Commercial Distribution

  • 08800019600237 ()
HCP-7000

  • Visual acuity projector

Chart Projector CCP-3100 - 08800019600220

chart projector is intended to be used to check eye optometry
Huvitz Co., Ltd.
CCP-3100
In Commercial Distribution

  • 08800019600220 ()
CCP-3100

  • Visual acuity projector

Knee Instruments - 07630542724060

GMK Sphere Fem S1 to 7L-Ultimate Tib 1 to 6L tray
Medacta International SA
02.12.10.8505
In Commercial Distribution

  • 07630542724060 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Knee Instruments - 07630542724077

GMK Sphere Fem S1 to 7R-Ultimate Tib 1 to 6R tray
Medacta International SA
02.12.10.8506
In Commercial Distribution

  • 07630542724077 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

CarboClear Cervical Plate System - 07290110207175

Used to direct the drill bit to prepare the screw pathway.
CARBOFIX ORTHOPEDICS LTD
Cervical Plate Drill Guide
In Commercial Distribution

  • 07290110207175 ()
PL940240

  • Surgical drill guide, reusable

Terumo® Advanced Perfusion System 1 - 00886799000847

Cable used to connect the data module to the intended device.
Terumo Cardiovascular Systems Corporation
804982
In Commercial Distribution

  • 00886799000847 ()
804982

  • Cardiopulmonary bypass system mounting unit

NeoPod "T" AC to DC Power Supply Cable - 00709078001192

AC to DC Power Supply Cable to provide 12VDC power to NeoPod "T" and Lava Bed Humidifier Cartridge.
WESTMED, INC.
9401R
In Commercial Distribution

  • 10709078001199 ()
  • 00709078001192 ()


  • Ventilator breathing circuit, single-use

BOND - 09349458005658

Used to print stick-on labels to attach to slides. The labelled slides are used on the BOND instrument.
LEICA BIOSYSTEMS MELBOURNE PTY LTD
Cognitive Labeller
In Commercial Distribution

  • 09349458005658 ()
S21.4605

  • Microscope slide stainer IVD

BOND - 09349458005290

Used to print stick-on labels to attach to slides. The labelled slides are used on the BOND instrument.
LEICA BIOSYSTEMS MELBOURNE PTY LTD
BOND Cognitive Slide Labeller
In Commercial Distribution

  • 09349458005290 ()
S21.4605

  • Microscope slide stainer IVD

BOND - 09349458002657

Used to print stick-on labels to attach to slides. The labelled slides are used on the BOND instrument.
LEICA BIOSYSTEMS MELBOURNE PTY LTD
Zebra GX430t Label Printer Spare
In Commercial Distribution

  • 09349458002657 ()
S21.4615

  • Microscope slide stainer IVD
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