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 Class Implantable

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Curing Light
Guilin Woodpecker Medical Instrument Co., Ltd.
MINIS
In Commercial Distribution

  • 06944843602295 ()


  • Dental/surgical polymerization lamp
No Description
Guilin Woodpecker Medical Instrument Co., Ltd.
MINIS
In Commercial Distribution

  • 06944843602288 ()


  • Dental/surgical polymerization lamp
Sleep Profiler RTA Software
ADVANCED BRAIN MONITORING, INC.
SP42-5402
In Commercial Distribution

  • 00850015266706 ()


  • Polysomnography analyser
BASIC VEIN ABLATION W BET
Cardinal Health 200, LLC
VEINBABETA
In Commercial Distribution

  • 50885425943850 ()
  • 10885425943852 ()
VEINBABETA

  • General surgical procedure kit, medicated
Innospire Elebance, Custom RTA, 6 pack.
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD
00
In Commercial Distribution

  • 00383730002644 ()
1105101

  • Benchtop nebulizer, non-heated
BASIC VEIN ABLATION W BET PK
Cardinal Health 200, LLC
SVA48VACHA
In Commercial Distribution

  • 50888439569948 ()
  • 10888439569940 ()
SVA48VACHA

  • General surgical procedure kit, medicated
STRL VEIN ABLATION PLUS W BET
Cardinal Health 200, LLC
VEINPLBETA
In Commercial Distribution

  • 50885425943836 ()
  • 10885425943838 ()
VEINPLBETA

  • General surgical procedure kit, medicated
Native Bet v 1-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10368597
In Commercial Distribution

  • 00630414988122 ()
A89L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
GSB Base, BET 4S Open Screws Implant
Nuvasive, Inc.
1639951
In Commercial Distribution

  • 00887517497529 ()


  • Device sterilization/disinfection container, reusable
The Illumina MiSeqDx is intended for targeted sequencing of human DNA using Illumina sequencing consumables and libraries prepared from human genomic DNA extracted from peripheral whole blood or formalin-fixed, paraffin-embedded (FFPE) tissue. Libraries are prepared by amplifying targets and adding sample indexes and capture sequences. Sample libraries are captured on a flow cell and sequenced on the instrument using sequencing by synthesis (SBS) chemistry. SBS chemistry uses a reversible-terminator method to detect single nucleotide bases as they are incorporated into growing DNA strands. The Real-Time Analysis (RTA) software performs image analysis and base calling, and assigns a quality score to each base for each sequencing cycle. The MiSeqDx instrument is not intended for whole genome or de novo sequencing. The MiSeqDx instrument is to be used with registered and listed, cleared, or approved IVD reagents and analytical software.
ILLUMINA, INC.
20014053
In Commercial Distribution

  • 00816270020699 ()
20014053

  • Nucleic acid sequence analyser IVD, next-generation sequencing (NGS)
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