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MICROTOOLS (Holding Pipette)

Arsci Inc. · Model H-3501 · UDI-DI 07540268000174

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 Holding Pipette is to be used by qualified personnel during In-Vitro Fertilization (IVF) or Assisted Reproduction Technology (ART) procedures in vitro, to secure the mature oocyte for when the Injection Pipette (or ICSI pipette) is utilized in the intracytoplasmic sperm injection (ICSI) of oocytes. The Holding Pipette also can help to ensure immobility of an embryo during biopsy procedures. 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.