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Needle Guide

CIVCO MEDICAL INSTRUMENTS CO., INC. · Model 842-004 · UDI-DI 10841436122242

MQEITX Prescription
1
510(k) clearances
173
Adverse events
1
Recalls
28
Facilities

Description

Sterile endocavity needle guide for use with GE Healtcare RIC5-9-D, RIC5-9W-RS. RIC6-12-D and Samsung Medison EV3-10B, V5-9 transducers. One-cell MEA: =80% embryo developed to expand cytoblast at 96 hours USP Endotoxin (LAL) tested and passed with 20 EU or less per device.

Recalls

DateFirmReason
2008-10-23Irvine Scientific Sales Co IncSmiths Medical International became aware that certain lots of Wallace oocyte Recovery Sets have a damaged needle tip.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.