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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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No Description
COSMEDENT, INC.
409202
In Commercial Distribution

  • D77940920219 ()


  • Dental matrix band kit
Pulsed Laser
Candela Corporation
9914-00-9084
In Commercial Distribution

  • 00817495022956 ()


  • Dermatological dye laser system
Fantastic-M orthodontic adhesive is designed to set on contact, “Cure-On Touch”, thus saving the dentist chair time. This procedure can also minimize erratic mixing procedures, and therefore reducing the possibility of errors caused by paste inconsistencies, a problem often encountered in other types of adhesives. Fantastic M has strong, reliable bond, mistake-proof cure-on-touch system: fast and easy to use, color stable and it economical in application. Fantastic-M starts to set only after the bracket is applied to the tooth, giving the operator the convenience and security of virtually unlimited working time. This material is very reliable due to its outstanding adhesive properties. Also, due to the soft filler, Fantastic-M is easy to clean. The material is highly tacky, therefore, brackets will not slide after being placed on the tooth, but rather they will remain immobilized until the material cures. Delayed cure time permits the operator to correct the position of the brackets up to 15 seconds after placement. Fantastic-M is very economical, unlike conventional adhesives that are normally mixed in excess.
DENT ZAR, INC.
1013
In Commercial Distribution

  • D83610131 ()
1013

  • Orthodontic bracket adhesive
The Modified Contact Heat Evoked Potential Stimulator (CHEPS) is an advanced, computerized thermal stimulator designed for advanced pain research. This non-invasive device can be used as stimulator for creating sensation and pain stimuli in the sensory nerves fibers. the CHEPS indicated for the use in evaluating the functionality of human reception and transmission of sensory pathways The Device includes: main electrical unit, external cooling unit, at least one thermode probe and accessories.
MEDOC LTD.
CHEPS
In Commercial Distribution

  • 07290103039318 ()


  • Thermotester, diagnostic
No Description
Hetaida Technology Co., Ltd
HTD8816C
In Commercial Distribution

  • 06970289030033 ()
  • 16970289030030 ()


  • Infrared patient thermometer, skin
No Description
Hetaida Technology Co., Ltd
HTD8818A
In Commercial Distribution

  • 16970289030023 ()
  • 06970289030026 ()


  • Infrared patient thermometer, skin
No Description
Hetaida Technology Co., Ltd
HTD8808C
In Commercial Distribution

  • 16970289030016 ()
  • 06970289030019 ()


  • Infrared patient thermometer, skin
48 “Tubing Length
URO CONCEPTS INC
48 inch
In Commercial Distribution

  • 00868636000418 ()
UROET48

  • Urine monitoring system collector
18 “Tubing
URO CONCEPTS INC
18 inch
In Commercial Distribution

  • 00868636000401 ()
UROET18

  • Urine monitoring system collector
URINE BAG, 2000ML, ANTI-REFLUX VALVE, EA.
ATLAS MEDICAL PRODUCTS LLC
AMPSLB04
In Commercial Distribution

  • 10812460028374 ()
  • 00812460028377 ()

  • URINE BAG, 2000ML, ANTI-REFLUX VALVE, EA.
AMPSLB04

  • Urine monitoring system collector
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