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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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Product Name : Teeth impressions kit This product is a convenience kit including One-time Putty 3EA and 6 dental impression trays. The contents of this kit are all registered in FDA. Its content, One-time Putty is a convenience kit that is changed only in packaging materials from Putty(MSP). These changes don't cause any change in the original functions of Putty. Importer as Retailer is exempt from FDA’S medical device, Establishment Registration, under 21 CFR, 807.65 (e) and (i).
NEOSIL Co., Ltd
NS005P-2
In Commercial Distribution

  • 08800026400134 ()


  • Dental impression material kit, single-use
Q-Stress Cardiac Stress- version 6 with adult and pediatric interpretation; includes current software CD and user manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Turnkey system with configured CPU and color LCD 24" monitor with 1920 x 1080 resolution; US/Canada power cord; Z200+ thermal printer (includes 2 starter packs of full-grid paper - 8"), Q-Stress basic transport cart with base and keyboard tray; AHA 10 wire, 12-lead lead set with medi-clips; I
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094355260 ()
QS-6ED-AEDAA

  • 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; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Turnkey system with configured CPU and color LCD 24" monitor with 1920 x 1080 resolution; US/Canada power cord; Z200+ thermal printer (includes 2 starter packs of full-grid paper - A4), Q-Stress basic transport cart with base and keyboard tray; AHA 10 wire, 12-lead lead set with medi-clips; I
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094355253 ()
QS-6ED-AFDAB

  • 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; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Turnkey system with configured CPU and color LCD 24" monitor with 1920 x 1080 resolution; Brazil power cord; Z200+ thermal printer (includes 2 starter packs of full-grid paper - 8"), Q-Stress basic transport cart with base and keyboard tray; AHA 10 wire, 12-lead lead set with medi-clips; No i
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094355215 ()
QS-6ED-EEDXA

  • 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; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Turnkey system with configured CPU and color LCD 24" monitor with 1920 x 1080 resolution; US/Canada power cord; Z200+ thermal printer (includes 2 starter packs of full-grid paper - A4), Q-Stress basic transport cart with base and keyboard tray; IEC 10 wire, 12-lead lead set with medi-clips; I
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094350869 ()
QS-6ED-AFEAX

  • Electrocardiographic lead set, reusable
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output and RScribe with Interpretation; Turnkey system with configured CPU and ELO brand capacitive color touchscreen 24 in. monitor with 1920 x 1080 resolution; International power cord; No printer, basic laser transport cart with base and back panel; IEC 10 wire, 12-lead lead set with medi-clips; I
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259339 ()
XSCRIBE-6EA-DEBAX

  • Cardiopulmonary stress exercise monitoring system computer
"In mode I, diagnosis aid mode, SOPROLIFE helps the dental practitioner to detect damage at various clinical stages in very high resolution. In mode II, treatment aid mode, SOPROLIFE helps dental practitioner to get a spatial map of unbroken tissue areas which are suspect. In daylight mode », SOPROLIFE enables you to visualize anatomical details invisible to the naked eye or with a mirror. It allows the dentist to show the difference between «before» and «after» care."
SOPRO
CAMERA S900 NTSC SANS SUPPORT
In Commercial Distribution

  • M430S90000041 ()
S_900_0004

  • Diagnostic-imaging multiformat camera
"In mode I, diagnosis aid mode, SOPROLIFE helps the dental practitioner to detect damage at various clinical stages in very high resolution. In mode II, treatment aid mode, SOPROLIFE helps dental practitioner to get a spatial map of unbroken tissue areas which are suspect. In daylight mode », SOPROLIFE enables you to visualize anatomical details invisible to the naked eye or with a mirror. It allows the dentist to show the difference between «before» and «after» care."
SOPRO
CAMERA S900 NTSC SOPROLIFE
In Commercial Distribution

  • M430S90000021 ()
S_900_0002

  • Diagnostic-imaging multiformat camera
Camera alone (without Box and accessories) "In mode I, diagnosis aid mode, SOPROLIFE helps the dental practitioner to detect damage at various clinical stages in very high resolution. In mode II, treatment aid mode, SOPROLIFE helps dental practitioner to get a spatial map of unbroken tissue areas which are suspect. In daylight mode », SOPROLIFE enables you to visualize anatomical details invisible to the naked eye or with a mirror. It allows the dentist to show the difference between «before» and «after» care."
SOPRO
SOPROLIFE NTSC
In Commercial Distribution

  • 03760278260304 ()
997043

  • Diagnostic-imaging multiformat camera
Product alone (without Box and accessories) "In mode I, diagnosis aid mode, SOPROLIFE helps the dental practitioner to detect damage at various clinical stages in very high resolution. In mode II, treatment aid mode, SOPROLIFE helps dental practitioner to get a spatial map of unbroken tissue areas which are suspect. In daylight mode », SOPROLIFE enables you to visualize anatomical details invisible to the naked eye or with a mirror. It allows the dentist to show the difference between «before» and «after» care."
SOPRO
SOPROLIFE P
In Commercial Distribution

  • 03760278260205 ()
997093

  • Diagnostic-imaging multiformat camera
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