OSUNG MND

OSUNG MND Co., Ltd. · Model BSF · UDI-DI 08800075621580

510(k) clearances

Adverse events

Recalls

Facilities

Description

A sterile, surgical device intended for the manual removal, through scraping, and collection of autogenous bone particles from a patient, typically as part of a dental surgical procedure. It consists of a handle with a scraping blade and a collection chamber. This is a single-use device.

Recalls

Date	Firm	Reason
2020-12-07	Oto Med Inc	During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.
2020-12-07	Oto Med Inc	During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.
2020-12-07	Oto Med Inc	During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.

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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.