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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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HL 5000, KIT IIC 10 85 BL HEARLINK 5000
Sbo Hearing A/S
197719
In Commercial Distribution

  • 05714464002160 ()


  • Air-conduction hearing aid, canal
HL 5000, KIT IIC 10 75 BL HEARLINK 5000
Sbo Hearing A/S
197716
In Commercial Distribution

  • 05714464002139 ()


  • Air-conduction hearing aid, canal
HL 7000, KIT IIC 10 85 BL HEARLINK 7000
Sbo Hearing A/S
197691
In Commercial Distribution

  • 05714464001880 ()


  • Air-conduction hearing aid, canal
HL 7000, KIT IIC 10 75 BL HEARLINK 7000
Sbo Hearing A/S
197688
In Commercial Distribution

  • 05714464001859 ()


  • Air-conduction hearing aid, in-the-ear
HL 9000, KIT IIC 10 85 BL HEARLINK 9000
Sbo Hearing A/S
197663
In Commercial Distribution

  • 05714464001606 ()


  • Air-conduction hearing aid, canal
HL 9000, KIT IIC 10 75 BL HEARLINK 9000
Sbo Hearing A/S
197660
In Commercial Distribution

  • 05714464001576 ()


  • Air-conduction hearing aid, canal
Patient chair, 4 wheels, upholstered seat and back, electrical
Vermund Larsen A/S
70041 'Support+' Surgeon's Chair
In Commercial Distribution

  • 05714339092180 ()


  • Assistive ergonomic chair, electrically-adjusted
Kit that includes 3CP Centrifuge, power cord, external power supply, 3CP Counterbalance, bag with centrifuge tools, display protection shield, and 3CP Manual.
Reapplix ApS
2
In Commercial Distribution

  • 05714188308005 ()


  • Haematological concentrate system centrifuge
This label goes directly on the centrifuge. The 3CP Centrifuge is a table-top centrifuge that creates the output (i.e., PRP).
Reapplix ApS
1
In Commercial Distribution

  • 05714188021577 ()


  • Haematological concentrate system centrifuge
Analyte specific reagent. Analytical and performance characteristics are not established. CMV Dextramer reagents react with T cell receptors on human CD8+ T cells restricted by the HLA allele of the Dextramer and specific for the CMV peptide displayed. CMV Dextramers comprise dextran polymer backbone carrying multiple fluorochrome molecules (PE) and multiple MHC-peptide complexes displaying a peptide epitope from a CMV antigen. CMV Dextramer reagents are provided in liquid form in volumes of 0,5 ml in buffer containing 1% bovine serum albumin (BSA) and 15 mmol/L NaN, pH 7.2.
Immudex ApS
HLA-B*0702 / RPHERNGFTVL / PE
In Commercial Distribution

  • 05714183000072 ()
WH02135A PE 50

  • T lymphocyte IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
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