International safety notice

Technical name: Introducers

Brazil / Anvisa · BRA · Jan 15, 2018

Key facts

Title Technical name: Introducers
Regulator Brazil / Anvisa
Country BRA
Brand Trade name: Prelude Introducing Sheath with Needle Technical name: Introducers ANVISA registration number: 80740950020 Risk class: II Affected model: PSI-5F-11-035-18G; Affected serial numbers: H775538;
Manufacturer EMPRESA DETENTORA DO REGISTRO MERIT MEDICAL COMERCIALIZAÇÃO DISTRIBUIÇÃO IMPORTAÇÃO E EXPORTAÇÃO DE PRODUTOS HOSPITALARES LTDA CNPJ 13200579000188 R DONA FRANCISCA N 8300 BLOCO 10 MODULO E JOINVILLE SC FABRICANTE MERIT MEDICAL SYSTEM INC AVENIDA MINAS GERAIS 1600 WEST MERIT PARKWAY SOUTH JORDAN UTAH 84095 ESTADOS UNIDOS EMAIL GABRIELAMUNOZMERITCOM
Models H1028228, H1067690, H998657, H955521, PSI-5F-11-035-18G, H930913, H950221, H1035126, H978305, H900044, H1068889, H1057247 and 102 more
Date Jan 15, 2018
Regulator page anvisa.gov.br

At a glance

  • No Recall
  • No Field safety notice
  • 1–9 Matching device models in FDA data

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About International device safety notices

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Source: National medical device regulators (as listed), compiled by Orca1

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