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Surgeon's Choice Card

OASIS MEDICAL, INC. · Model SCK 1000, B-SCK 1000 · UDI-DI 00845819006009

PZG Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Kit Packs Assembled from Non-Sterile Capped Product 1 eaches of Cystotome, Angled, 25g x 5/8"(0.5 x 16mm) (GTIN: 00845819001493) 1 eaches of Cortical Cleaving Hydrodissector, 27g x 7/8" (0.4 x 22mm), 11mm Bend, Round End (GTIN: 00845819005958) 1 eaches of Cortical Cleaving Hydrodissector, 27g x 7/8" (0.4 x 22mm), Flat End, 11mm Bend (GTIN: 00845819005989) 1 eaches of Sideport Knives, Safety Line, Thin Slit, Safety Line (Single Bevel Blade) (GTIN: 00845819005675)

Recalls

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