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

  • 09120073931931 ()
FHCS3043

  • General-purpose multi-parameter bedside monitor
EZ™ Software CD & Data Cable for ECG Monitor
VASOMEDICAL, INC.
Model EZ
In Commercial Distribution

  • 00817980021396 ()
A13-0040

  • Electrocardiographic long-term ambulatory recording analyser application software
Soprano® 10 Livento® press Shade C-D Kit
Cendres+Métaux SA
08055074
In Commercial Distribution

  • 07640173094791 ()
08055074

  • Dental appliance fabrication material, ceramic
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
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
BioPlex® 2200 HIV Ag-Ab Assay Protocol Files CD SW4.2_v4
BIO-RAD LABORATORIES, INC.
SW4.2_v4
In Commercial Distribution

  • 03610520519813 ()

  • 1 Each
6653475A

  • Laboratory instrument/analyser application software IVD
BioPlex 2200 Syphilis Total & RPR Assay Protocol File CD SW4.3_v1
BIO-RAD LABORATORIES, INC.
4.3_v1
In Commercial Distribution

  • 03610520138267 ()

  • 1 Each
12000657

  • Treponema pallidum reagin antibody IVD, reagent
  • Treponema pallidum total antibody IVD, kit, fluorescent immunoassay
BioPlex 2200 25-OH Vitamin D Assay Protocol File CD SW4.3_v5
BIO-RAD LABORATORIES, INC.
4.3_v5
In Commercial Distribution

  • 03610521185987 ()

  • 1 Each
12006557

  • Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay
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
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
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
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
CD Ø 1.45 Core Drill, left-hand cut, for Service Set
Institut Straumann AG
non-surgically Invasive Instruments
In Commercial Distribution

  • 07630031733665 ()

  • Outer Diameter: 1.45 Millimeter
046.756

  • Dental implant internal thread shaping tool
CD Ø 1.3 Core Drill, left-hand cut, for Service Set
Institut Straumann AG
non-surgically Invasive Instruments
In Commercial Distribution

  • 07630031733122 ()

  • Outer Diameter: 1.3 Millimeter
026.0127

  • Dental implant internal thread shaping tool
SHERLOCK 3CG FOR SR6 USB UPGRADE KIT W/ IFU CD
Bard Access Systems, Inc.
9770137
In Commercial Distribution

  • 00801741124396 ()
9770137

  • Central venous catheter navigation system, electrocardiographic/magnetic
No Description
Changzhou Care-de Sanitary Material Co.,Ltd.
21”*225 ft
In Commercial Distribution

  • 06976289698013 ()


  • Examination/treatment table paper
No Description
Changzhou Care-de Sanitary Material Co.,Ltd.
42”*30”
In Commercial Distribution

  • 06976289697016 ()


  • Patient gown, single-use
No Description
Changzhou Care-de Sanitary Material Co.,Ltd.
23”*36”
In Commercial Distribution

  • 06976289696019 ()


  • Absorbent underpad, non-antimicrobial, single-use
No Description
Changzhou Care-de Sanitary Material Co.,Ltd.
33*45cm
In Commercial Distribution

  • 06976289695012 ()


  • Dental bib
No Description
Zimmer, Inc.
42-5558-034-15
In Commercial Distribution

  • 00889024557543 ()

  • Size CD, 15 mm, Thickness
42-5558-034-15

  • Knee arthroplasty wedge
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