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Surgeon's Choice Card

OASIS MEDICAL, INC. · Model SCK-2012, B-SCK-2012 · UDI-DI 00845819003138

PZG
0
510(k) clearances
4
Adverse events
6
Recalls
28
Facilities

Description

Kit Packs Assembled from Non-Sterile Capped Product: Irrigating Cystotome, Formed, 27 g x 5/8”, Non-sterile (GTIN: 00845819006078) Nucleus Hydrodissection Cannula 27 g x 7/8”, Helsinki (Curved, Horizontal Flow) (GTIN: 00845819001202)

Recalls

DateFirmReason
2021-11-17Beaver Visitec International, Inc.Kit packaging may have small holes compromising product sterility
2021-11-17Beaver Visitec International, Inc.Kit packaging may have small holes compromising product sterility
2021-11-17Beaver Visitec International, Inc.Kit packaging may have small holes compromising product sterility
2021-11-17Beaver Visitec International, Inc.Kit packaging may have small holes compromising product sterility
2021-11-17Beaver Visitec International, Inc.Kit packaging may have small holes compromising product sterility
2021-11-17Beaver Visitec International, Inc.Kit packaging may have small holes compromising product sterility

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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.