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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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Welch Allyn OAE Hearing Screener with Charging Stand, Thermal Printer, Bluetooth Wireless and USB Connectivity, Single Use Ear Tip Starter Kit -- 3 mm to 15 mm sizes (#39420), Calibration Certificate, and Data Manager Software; 100-240 V, 50-60 Hz AC, Lithium-Ion Integrated Battery; IEC Plug Type-B, -C, -G, and -I
WELCH ALLYN, INC.
901031
Not in Commercial Distribution

  • 00732094186215 ()
39400

  • Direct otoscope/audiometer
Welch Allyn OAE Hearing Screener with Charging Stand, Bluetooth Wireless and USB Connectivity, Single Use Ear Tip Starter Kit—3mm to 15 mm sizes (#39420), Calibration Certificate, and Data Manager Software; 100- 240 V, 50- 60 Hz AC, Lithium-Ion Integrated Battery, IEC Plug Type-B, -C, - G, and -I
WELCH ALLYN, INC.
901031
In Commercial Distribution

  • 00732094237979 ()
39500-NP

  • Otoacoustic emission system, battery-powered
BEQ-HMO 71000 Quadrox i Adult with integral filter, BO-VHK 71000 Venous Reservoir, Blood Transfer Bag 1000 ml - 2 spike ports, BEQ-RF32 RotaFlow, BC 60 plus, CDI Sat Cell 1/2" System 100, CDI Sat Cell 1/4" System 100, Prebypass filter w/o Vent Porous Media 3/8x1/2, Gas Filter.
DATASCOPE CORP.
BEQ-TOP 40010
Not in Commercial Distribution

  • 00607567210479 ()
701067364R02

  • Cardiopulmonary bypass system blood tubing set
Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered inlays-and onlays by the direct or indirect method, as well as, fabrication of extraorally tempered custom made veneers. A highly polishable, photocuring, Nano-Micro Hybrid composite for anterior and posterior restorations.
DENT ZAR, INC.
0018
In Commercial Distribution

  • D83600180 ()
0018

  • Dental composite resin
Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered inlays-and onlays by the direct or indirect method, as well as, fabrication of extraorally tempered custom made veneers. A highly polishable, photocuring, Nano-Micro Hybrid composite for anterior and posterior restorations.
DENT ZAR, INC.
0017
In Commercial Distribution

  • D83600170 ()
0017

  • Dental composite resin
Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered inlays-and onlays by the direct or indirect method, as well as, fabrication of extraorally tempered custom made veneers. A highly polishable, photocuring, Nano-Micro Hybrid composite for anterior and posterior restorations.
DENT ZAR, INC.
0016
In Commercial Distribution

  • D83600160 ()
0016

  • Dental composite resin
Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered inlays-and onlays by the direct or indirect method, as well as, fabrication of extraorally tempered custom made veneers. A highly polishable, photocuring, Nano-Micro Hybrid composite for anterior and posterior restorations.
DENT ZAR, INC.
0015
In Commercial Distribution

  • D83600150 ()
0015

  • Dental composite resin
Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered inlays-and onlays by the direct or indirect method, as well as, fabrication of extraorally tempered custom made veneers. A highly polishable, photocuring, Nano-Micro Hybrid composite for anterior and posterior restorations.
DENT ZAR, INC.
0013
In Commercial Distribution

  • D83600130 ()
0013

  • Dental composite resin
Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered inlays-and onlays by the direct or indirect method, as well as, fabrication of extraorally tempered custom made veneers. A highly polishable, photocuring, Nano-Micro Hybrid composite for anterior and posterior restorations.
DENT ZAR, INC.
0012
In Commercial Distribution

  • D83600120 ()
0012

  • Dental composite resin
Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered inlays-and onlays by the direct or indirect method, as well as, fabrication of extraorally tempered custom made veneers. A highly polishable, photocuring, Nano-Micro Hybrid composite for anterior and posterior restorations.
DENT ZAR, INC.
0011
In Commercial Distribution

  • D83600110 ()
0011

  • Dental composite resin
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