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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

BioPlex 2200 - 00847865002448

ANA Screen with MDSS Assay Protocol File CD, SW4_v2
BIO-RAD LABORATORIES, INC.
SW4_V2
Not in Commercial Distribution

  • 00847865002448 ()

  • 1 Each
6651170C

  • Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex

BioPlex 2200 - 00847865012331

ANA Screen with MDSS Assay Protocol File CD, SW4.1_v2
BIO-RAD LABORATORIES, INC.
SW4.1_V2
In Commercial Distribution

  • 00847865012331 ()

  • 1 Each
6651170D

  • Multiple antinuclear antibody (ANA) screening IVD, kit, multiplex

Task Force® Monitor Software - 09120073931931

Task Force® Monitor software incl. customer CD (multilingual)
CNSystems Medizintechnik GmbH
V2.3
In Commercial Distribution

  • 09120073931931 ()
FHCS3043

  • General-purpose multi-parameter bedside monitor

BioPlex 2200 - 03610520563939

BioPlex 2200 HIV Ag-Ab Assay Protocol File CD SW4.3_v5
BIO-RAD LABORATORIES, INC.
4.3_v5
In Commercial Distribution

  • 03610520563939 ()

  • 1 Each
12001442

  • Laboratory instrument/analyser application software IVD

BioPlex 2200 - 03610520506462

BioPlex 2200 Lyme Total Assay Protocol File CD SW4.3_v1.0
BIO-RAD LABORATORIES, INC.
4.3_v1.0
In Commercial Distribution

  • 03610520506462 ()

  • 1 Each
12000883

  • Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, chemiluminescent immunoassay
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