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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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8F PLASTIC Pro-Fuse® CT PORT W/ATTACHABLECT PORT W/AT ChronoFlex®POLYURETHANE CATHETERCATHETER
Medical Components, Inc.
MRCTT80001OR
Not in Commercial Distribution

  • 50884908149000 ()
  • 00884908149005 ()
MRCTT80001OR

  • Vascular port/catheter
ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
STERNGOLD DENTAL LLC
812397
In Commercial Distribution

  • 00841549103520 ()


  • Dental implant suprastructure, permanent, preformed
ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
STERNGOLD DENTAL LLC
812396
In Commercial Distribution

  • 00841549103513 ()


  • Dental implant suprastructure, permanent, preformed
ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
STERNGOLD DENTAL LLC
812395
In Commercial Distribution

  • 00841549103506 ()


  • Dental implant suprastructure, permanent, preformed
ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
STERNGOLD DENTAL LLC
812394
In Commercial Distribution

  • 00841549103490 ()


  • Dental implant suprastructure, permanent, preformed
ERA abutments provide a resilient attachment with universal hinge movement. Available as one piece straight abutment-screwed into implant and as a two-piece angled abutment (angled attachment cemented into abutment base, and base screed into implant).
STERNGOLD DENTAL LLC
812393
In Commercial Distribution

  • 00841549103483 ()


  • Dental implant suprastructure, permanent, preformed
Silicone-Based Personal Lubricant
CC Wellness LLC
72224
In Commercial Distribution

  • 10796494002978 ()
  • 00796494002971 ()


  • Sexual lubricant
Hybrid Personal Lubricant
CC Wellness LLC
72222
In Commercial Distribution

  • 10796494002961 ()
  • 00796494002964 ()


  • Sexual lubricant
Water-based Personal Lubricant
CC Wellness LLC
72221
In Commercial Distribution

  • 10796494002954 ()
  • 00796494002957 ()


  • Sexual lubricant
The xCupTM for use with the xReaderTM is for in vitro diagnostic use and is intended for prescription use in laboratories, point-of-care and workplaces by trained users. The test is not intended for over-the-counter use. The test device cannot be read visually and must be used with the xReaderTM. The xCupTM qualitatively detects drug classes in human urine at the following cut-off concentrations: Amphetamines at 500 ng/ml; Barbiturates at 300 ng/mL; Benzodiazepines at 300 ng/mL; Cocaine at 150 ng/mL; Methamphetamines at 500 ng/mL; Methadone at 300 ng/mL; Morphine at 300 ng/mL and 2000 ng/mL; Oxycodone at 100 ng/mL; Phencyclidine at 25 ng/mL; and Marijuana at 50 ng/mL. Configurations of the xCupTM may consist of any combination of the listed drug analytes. The xCupTM only provides a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography / mass spectrometry (GC/MS), high performance liquid chromatography (HPLC) or liquid chromatography / tandem mass spectrometry (LC/MS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
ESCREEN, INC.
DUE-1117X-071-01
In Commercial Distribution

  • 10867802000273 ()
  • 00867802000276 ()
DUE-1117X-071-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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