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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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Blood Bank Computer System
2.0.0
In Commercial Distribution

  • 00860009119406 ()


  • Blood bank information system application software
HUMAC Biodex System4 Extremity System; Dynamometer – Refurbished
COMPUTER SPORTS MEDICINE INC.
503680
In Commercial Distribution

  • 00860139000360 ()
503680

  • Back/leg/chest dynamometer
HUMAC Biodex System3 Rev1 Extremity System; Dynamometer – Refurbished
COMPUTER SPORTS MEDICINE INC.
503679
In Commercial Distribution

  • 00860139000353 ()
503679

  • Back/leg/chest dynamometer
HUMAC Biodex System3 Rev0 Extremity System; Dynamometer – Refurbished
COMPUTER SPORTS MEDICINE INC.
503678
In Commercial Distribution

  • 00860139000346 ()
503678

  • Back/leg/chest dynamometer
HUMAC Biodex System2 Extremity System; Dynamometer – Refurbished
COMPUTER SPORTS MEDICINE INC.
503677
In Commercial Distribution

  • 00860139000339 ()
503677

  • Back/leg/chest dynamometer
HUMAC Cybex NORM Extremity System; Dynamometer – Refurbished
COMPUTER SPORTS MEDICINE INC.
504192
In Commercial Distribution

  • 00860139000322 ()
504192

  • Back/leg/chest dynamometer
The NIDEK NON-MYDRIATIC AUTO FUNDUS CAMERA, AFC-330 captures fundus images using a built-in color CCD camera without the use of mydriatic agents. The AFC-330 is useful not only for ophthalmology but also for fundus photography in medical examinations such as for diabetes. With this single device, registration of patient information, image capture, and viewing of captured images are possible. In addition, captured images can be output to a USB flash drive, and printed using a printer. By connecting a personal computer (PC) to the device via a LAN and installing the optional image filing system software, images captured by this device can be transferred to the PC at high speed, and viewed and managed on the PC.
NIDEK CO.,LTD.
AFC-330
In Commercial Distribution

  • 04987669100554 ()


  • Ophthalmic fundus camera
  • Eye anterior segment analyser software
  • Posterior eye segment analyser software
Computer-assisted dental injection syringe
Rønvig Dental Manufacturing A/S
2118
In Commercial Distribution

  • 05713513000942 ()


  • Dental computer assisted anaesthesia injection unit
Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q Wired Acquisition Module with Trigger Module for TTL/analog signal output; Software kit; No power cord; No printer, no transport cart; AHA 10 wire, 12-lead lead set with 25" leadwires with pinch for AM12Q; No isolation transformer ; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094346633 ()
QS-6AC-XXBXX

  • Cardiopulmonary stress exercise monitoring system computer
Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; AM12Q Wired Acquisition Module; Software kit; No power cord; No printer, no transport cart; AHA 10 wire, 12-lead lead set with medi-clips; No isolation transformer ; Report Export + XML Orders (required for HL7 interface)
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094343410 ()
QS-6CC-XXDXA

  • Cardiopulmonary stress exercise monitoring system computer
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