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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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CellSearch - 10888385000016

Circulating Tumor Cell Kit (Epithelial)
MENARINI SILICON BIOSYSTEMS, INC.
7900001
In Commercial Distribution

  • 10888385000016 ()
7900001

  • Multiple CD cell marker IVD, kit, enzyme immunohistochemistry

Cochlear™ Custom Sound Suite Version 5 - 09321502038829

CD
COCHLEAR LIMITED
P772796
In Commercial Distribution

  • 09321502038829 ()
P772796

  • Audiometric/hearing device software

Torque ratchet - 04063494000785

No Description
Josef Ganter Feinmechanik GmbH
CD
In Commercial Distribution

  • 04063494000785 ()


  • Dental torque wrench

Fisher & Paykel Healthcare - 09420012424990

INFOSMART CD
FISHER & PAYKEL HEALTHCARE LIMITED
900SW100
In Commercial Distribution

  • 09420012424990 ()
900SW100

  • Ventilator application software

Mariner MIS - 10889981178222

CD DRIVER
Seaspine Orthopedics Corporation
MM2-000220
In Commercial Distribution

  • 10889981178222 ()
MM2-000220

  • Orthopaedic implant driver

Mariner MIS - 10889981218515

CD Driver
Seaspine Orthopedics Corporation
MM2-100220
In Commercial Distribution

  • 10889981218515 ()
MM2-100220

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Persona® The Personalized Knee System - 00889024203426

No Description
Zimmer, Inc.
00-5907-080-76
In Commercial Distribution

  • 00889024203426 ()

  • C-D
00-5907-080-76

  • Device sterilization/disinfection container, reusable

Persona® The Personalized Knee System - 00889024204744

No Description
Zimmer, Inc.
00-5907-082-90
In Commercial Distribution

  • 00889024204744 ()

  • CD
00-5907-082-90

  • Device sterilization/disinfection container, reusable

Custom Sound Suite 4.4 CD - 09321502033381

Version 4.4 CD
COCHLEAR LIMITED
P705394
In Commercial Distribution

  • 09321502033381 ()
P705394

  • Audiometric/hearing device software

Mariner MIS - 10889981178499

CD MAIN ARM
Seaspine Orthopedics Corporation
MM2-000520
In Commercial Distribution

  • 10889981178499 ()
MM2-000520

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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