International safety notice
Alert 2639 (Technovigilance) - Scitech Produtos Médicos Ltda.
Brazil / Anvisa · BRA · Aug 8, 2018
Key facts
| Title | Alert 2639 (Technovigilance) - Scitech Produtos Médicos Ltda. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: Solaris Endoprosthesis - Vascular Stent Technical Name: Endoprosthesis (Vascular) ANVISA registration number: 10413960173 Risk Class: III Affected model: NA Affected serial numbers: 111723 - Endoprotese Solaris 08X060MM 130CM Scitech 111724 - Endoprotese Solaris 08X080MM 130CM Scitech Lots: 31683, 31684, 31685, 31888 and 31891 |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO SCITECH PRODUTOS MÉDICOS LTDA CNPJ 14337707000122 RUA 06 C18 C19 QD 21 LT 01 E 44 POLO EMPRESARIAL DE GOIÁS APARECIDA DE GOIÂNIA GO TEL 62 3625 5002 EMAIL RPIMENTASCITECHMEDCOM FABRICANTE DO PRODUTO SCITECH PRODUTOS MÉDICOS LTDA RUA 06 C18 C19 QD 21 LT 01 E 44 POLO EMPRESARIAL DE GOIÁS BRASIL |
| Models | 111723, 31685, 31888, 130CM, 31683, 10413960173, 111724, 31891, 31684 |
| Date | Aug 8, 2018 |
| 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