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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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Persona® The Personalized Knee® - 00889024238930

No Description
Zimmer, Inc.
42-5176-003-13
In Commercial Distribution

  • 00889024238930 ()

  • +6 Thickness, Size CD
42-5176-003-13

  • Knee tibia prosthesis trial, reusable

Persona® The Personalized Knee® - 00889024238916

No Description
Zimmer, Inc.
42-5176-003-03
In Commercial Distribution

  • 00889024238916 ()

  • +0 Thickness, Size CD
42-5176-003-03

  • Knee tibia prosthesis trial, reusable

Persona® The Personalized Knee® - 00889024238473

No Description
Zimmer, Inc.
42-5170-003-13
In Commercial Distribution

  • 00889024238473 ()

  • +6mm Thickness, Size CD
42-5170-003-13

  • Knee tibia prosthesis trial, reusable

Persona® The Personalized Knee® - 00889024238459

No Description
Zimmer, Inc.
42-5170-003-03
In Commercial Distribution

  • 00889024238459 ()

  • +0mm Thickness, Size CD
42-5170-003-03

  • Knee tibia prosthesis trial, reusable

HyperSound - 00869138000203

Directed audio solution employing a fundamentally new way to deliver sound. Device is intended to improve sound clarity and speech intelligibility for individuals with hearing loss. The device is programmable and customizable by a hearing professional to a listener's hearing profile and preferences and other operating parameters are adjustable by the user. The device consists of an amplifier and specialized speakers connectable to an audio source (e.g., television, CD player); the speakers emit an ultrasonic beam with sound waves reproduced within the beam directed at the user. It is intended to be used with or without a hearing aid(s). An internal tinnitus software module may be activated and fitted by a hearing care professional for patient home use in the temporary relief of tinnitus symptoms. Upon module activation the device generates and delivers personalized sound output to tinnitus patients with or without hearing loss and with or without hearing aids.
TURTLE BEACH CORPORATION
HyperSound Clear 500P
Not in Commercial Distribution

  • 00869138000203 ()
HPS-0500-04

  • Directed listening device

M SERIES - 00847946005252

Defibrillator ,MAIN, BASIC-3 SPO2/12LEAD AC/EL/RC/SM/CD
Zoll Medical Corporation
40021211000003010
In Commercial Distribution

  • 00847946005252 ()

  • 6.8" x 10.3" x 8.2"


  • Rechargeable professional automated external defibrillator

M SERIES - 00847946002992

Defibrillator ,MAIN,BASIC-3,3/5LEAD,DC,EL,RC,SM,CD, ENG
Zoll Medical Corporation
40010021000003010
In Commercial Distribution

  • 00847946002992 ()

  • 6.8" x 10.3" x 8.2"


  • Rechargeable professional automated external defibrillator

BioPlex 2200 - 00847865012508

APLS IgG, IgM and IgA Assay Protocol File CD, SW4_v1
BIO-RAD LABORATORIES, INC.
SW4_1
In Commercial Distribution

  • 00847865012508 ()

  • 1 Each
6651975A

  • Phospholipid antibody IVD, kit, multiplex

Phoenix Diagnostics - 00852676007049

Wash/CD Pack 248 for Bayer / Ciba-Corning Blood Gas Systems
PHOENIX DIAGNOSTICS, INC.
3-221
In Commercial Distribution

  • 01085267600704 ()
  • 00852676007049 ()

  • Total Volume: 460 Milliliter


  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator

NA - 07630031733672

CD Ø 1.65 Core Drill, left-hand cut, for Service Set
Institut Straumann AG
non-surgically Invasive Instruments
In Commercial Distribution

  • 07630031733672 ()

  • Outer Diameter: 1.65 Millimeter
046.757

  • Dental implant internal thread shaping tool
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