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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
Microgenics Corporation
963602
In Commercial Distribution

  • 00884883005891 ()


  • HIV1 nucleic acid IVD, control
The Home Access Health Corporation HIV-1 Standard Test System is intended for use by persons to anonymously determine if antibodies to HIV-1 (Human Immunodeficiency Virus, Type-1) can be detected in their blood. It is intended for home use by persons with little or no experience in obtaining blood spot samples for medical testing. The kit contains all components necessary to collect and send your blood spot sample to Home Access laboratory for testing.
Home Access Health Corporation
21
In Commercial Distribution

  • M769HIVSTANDARD211 ()


  • Capillary blood collection set, home-use
The Home Access Health Corporation HIV-1 Standard Test System is intended for use by persons to anonymously determine if antibodies to HIV-1 (Human Immunodeficiency Virus, Type-1) can be detected in their blood. It is intended for home use by persons with little or no experience in obtaining blood spot samples for medical testing. The kit contains all components necessary to collect and send your blood spot sample to a qualified laboratory for testing.
Home Access Health Corporation
20
In Commercial Distribution

  • M769HIVEXPRESS201 ()


  • Capillary blood collection set, home-use
The MacoMix HM20 device and optional Hemolog 6 software system is an automated blood mixer used during blood donation to mix the anti-coagulant contained in the blood bag with the whole blood collected during donation and automatically clamping the tube when the preset target volume has been reached.
MACO PHARMA
9HHM-020-F
In Commercial Distribution

  • 03567051503227 ()
9HHM-020-F

  • Blood donation rocker
No Description
W.H. Holden, Inc.
10-5502
In Commercial Distribution

  • D9281055020 ()


  • Dental cheek retractor, professional, reusable
Brush for composite
TOKUYAMA DENTAL CORPORATION
10762
In Commercial Distribution

  • 04548190107629 ()
  • 94548190107622 ()


  • Dental material application tool, reusable
No Description
SIZEWISE RENTALS, L.L.C.
WCADV24
In Commercial Distribution

  • 00845699000289 ()


  • Bariatric wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible
No Description
SIZEWISE RENTALS, L.L.C.
WC24
In Commercial Distribution

  • 00845699000111 ()


  • Bariatric wheelchair, attendant/occupant-driven, rear-wheels-operated, non-collapsible
General purpose laboratory centrifuge for sample separation.
DRUCKER DIAGNOSTICS
00-284-009-000
In Commercial Distribution

  • 00858092006994 ()
00-284-009-000

  • General-purpose centrifuge IVD
Dental bur holder
HAGER WORLDWIDE, INC.
355240
In Commercial Distribution

  • D2483552400 ()


  • Device sterilization/disinfection container, reusable
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