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MICROTOOLS (Denuding Pipette)

Arsci Inc. · Model D-170 · UDI-DI 07540268000433

510(k) clearances

Adverse events

Recalls

Facilities

Description

A non-invasive, single-use micro-manipulation pipette used in the laboratory to inject, denude, mobilize, remove, aspirate, incise, manipulate or separate cells for the duration of In-Vitro Fertilization (IVF), Assisted Reproductive Technologies (ART), and Reproductive Medicine (RM) procedures. The Denuding Pipette is to be used by qualified personnel during In-Vitro Fertilization (IVF) or Assisted Reproduction Technology (ART) procedures in vitro, for the removal or separation of cumulus cells from the oocyte. The Denuding Pipette is also used for transferring oocytes, blastomeres, and embryos. Intended for one-time use.

Recalls

Date	Firm	Reason
2019-03-27	CooperSurgical, Inc.	ICSI CUSTOM MICROPIPETTES the thirty-degree bend is absent
2008-03-02	Cook Vascular Inc.	mislabeled - 300 micron flexipets labeled as 130 micron and vice versa
2008-03-02	Cook Vascular Inc.	mislabeled - 300 micron flexipets labeled as 130 micron and vice versa
2007-12-17	Cook Vascular Inc.	mislabeled - 300 micron flexipets were labeled as 80 microns

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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.