International safety notice

Technical name: Coverage

Brazil / Anvisa · BRA · Dec 14, 2016

Key facts

Title Technical name: Coverage
Regulator Brazil / Anvisa
Country BRA
Brand Trade name: PHMB antimicrobial foam cover Technical name: Cover ANVISA registration number: 10349000446 Risk class: IV Affected model: 55511AMDX and 55512AMDX
Manufacturer NOTIFICAÇÃO FEITA PELA EMPRESA EM ATENDIMENTO À RDC 232012 QUE DISPÕE SOBRE A OBRIGATORIEDADE DE EXECUÇÃO E NOTIFICAÇÃO DE AÇÃO DE CAMPO POR PARTE DO DETENTOR DO REGISTRO DO PRODUTO PARA A SAÚDE EMPRESA DETENTORA DO REGISTRO AUTO SUTURE AV JORNALISTA ROBERTO MARINHO 85 10º ANDAR CEP 04675010 SÃO PAULO FABRICANTE MEDTRONIC
Models 10349000446, 55512AMDX, 55511AMDX
Date Dec 14, 2016
Regulator page anvisa.gov.br

At a glance

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

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

About International device safety notices

Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.

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

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