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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

Mariner MIS - 10889981178406

CD TOWER ARM
Seaspine Orthopedics Corporation
MM2-000420
In Commercial Distribution

  • 10889981178406 ()
MM2-000420

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Mariner Deformity - 10889981293161

CD Tip, Offset
Seaspine Orthopedics Corporation
MD2-103016
In Commercial Distribution

  • 10889981293161 ()
MD2-103016

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Mariner Deformity - 10889981293154

CD Tip, Straight
Seaspine Orthopedics Corporation
MD2-103015
In Commercial Distribution

  • 10889981293154 ()
MD2-103015

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Mariner MIS - 10889981218546

CD Main Arm
Seaspine Orthopedics Corporation
MM2-100520
In Commercial Distribution

  • 10889981218546 ()
MM2-100520

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Mariner MIS - 10889981218522

CD Tower Arm
Seaspine Orthopedics Corporation
MM2-100420
In Commercial Distribution

  • 10889981218522 ()
MM2-100420

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Medtronic Reusable Instruments - 00673978156057

CD 84604 SPREADER
MEDTRONIC SOFAMOR DANEK, INC.
X1295-001
Not in Commercial Distribution

  • 00673978156057 ()


  • Bone distraction forceps

GN ReSound - 05708296222155

CD, AVENTA 2.9
Gn Hearing A/S
16861900
In Commercial Distribution

  • 05708296222155 ()


  • Audiometric/hearing device software

Media Writer CD - 00850677007136

Media Writer CD
HYLAND LLC
5
In Commercial Distribution

  • 00850677007136 ()


  • Radiology DICOM image processing application software

DMC-EZ - 00850018049115

DICOM CD Viewer
Storage Solutions Technology Group Inc.
DMC-EZ DICOM
In Commercial Distribution

  • 00850018049115 ()
DMC-EZ DICOM

  • Multidisciplinary medical image management software

Actiware - 00606959021457

Actiware Software CD
Respironics, Inc.
Actiware Software CD - 6
In Commercial Distribution

  • 00606959021457 ()
1104775

  • Kinesiology ambulatory recorder
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