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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Kit of 12 disposable Unyvero LRT BAL Cartridges, including sample tubes, sample tube caps and sample transfer tools, for testing 12 patient samples in total. Each sample also requires 1 Unyvero M1 Master Mix Tube for processing (not contained in this kit)
Curetis GmbH
LRT BAL Cartridge Kit
Not in Commercial Distribution

  • 04260364750058 ()
10091

  • Multiple respiratory disease-associated bacteria/antimicrobial resistance nucleic acid IVD, kit, nucleic acid technique
A reagent kit for use with Acuitas AMR Gene Panel assay; consisting of two (2) vials of PCR Master Mix and eight (8) vials of dried Assay Control which comprise enough reagents required to perform eight (8) Acuitas AMR Gene Panel assays.
Opgen, Inc.
KT03U01-2
Not in Commercial Distribution

  • 01812125010036 ()
KT03U01-2

  • Nucleic acid amplification mastermix kit IVD
A reagent kit for use with Acuitas AMR Gene Panel assay; consisting of two (2) vials of PCR Master Mix and eight (8) vials of dried Assay Control which comprise enough reagents required to perform eight (8) Acuitas AMR Gene Panel assays.
Opgen, Inc.
KT03U01-2
Not in Commercial Distribution

  • 20812125010031 ()
KT03U01-2

  • Nucleic acid amplification mastermix kit IVD
HemoMix 3 is an automated blood monitor/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 target volume has been reached (Version with WiFi option installed)
DELCON SRL
HMIX3.WIFI
In Commercial Distribution

  • 08033928530054 ()


  • Blood donation rocker
HemoMix 3 is an automated blood monitor/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 target volume has been reached (Version with LAN option installed)
DELCON SRL
HMIX3.LAN
In Commercial Distribution

  • 08033928530030 ()


  • Blood donation rocker
HemoMix 3 is an automated blood monitor/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 target volume has been reached (Version with internal RFID option installed)
DELCON SRL
HMIX3.485.RFID
In Commercial Distribution

  • 08033928530023 ()


  • Blood donation rocker
HemoMix 3 is an automated blood monitor/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 target volume has been reached (Version with LAN and integrated RFID options installed)
DELCON SRL
HMIX3.LAN.RFID
In Commercial Distribution

  • 08033928530047 ()


  • Blood donation rocker
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
W-Bone is a xenograft biomaterial composed of hydroxyapatite from bovine origin. It is intended to fill, augment, or reconstruct periodontal defects and/or bony defects of the upper or lower jaw. W-Bone is supplied as a mix of cancellous and cortical particles in a single use thermoformed blister, packaged in a secondary thermoformed blister and sterilized by gamma irradiation.
Wishbone
WHA200
In Commercial Distribution

  • 05430001477115 ()

  • Weight: 2.0 Gram


  • Dental bone matrix implant, animal-derived
W-Bone is a xenograft biomaterial composed of hydroxyapatite from bovine origin. It is intended to fill, augment, or reconstruct periodontal defects and/or bony defects of the upper or lower jaw. W-Bone is supplied as a mix of cancellous and cortical particles in a single use thermoformed blister, packaged in a secondary thermoformed blister and sterilized by gamma irradiation.
Wishbone
WHA100
In Commercial Distribution

  • 05430001477108 ()

  • Weight: 1.0 Gram


  • Dental bone matrix implant, animal-derived
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