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AESCULAP

Aesculap AG · Model SF814R · UDI-DI 04038653014873

KAM Prescription
10
510(k) clearances
61
Adverse events (1 deaths)
2
Recalls
56
Facilities

Description

Injection Cannula, straight, (140 mm), diam. 0,80 mm, bayonet-shaped, tip length: 25 mm, luer lock, non-sterile, reusable

Recalls

DateFirmReason
2015-04-28Acclarent, Inc.Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date.
2013-05-03Surgical Instrument Service And Savings, Inc.The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

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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.