FDA Device Intelligence
HomeOASIS MEDICAL, INC. › Surgeon's Choice Card

Surgeon's Choice Card

OASIS MEDICAL, INC. · Model SCK 2006, B-SCK 2006 · UDI-DI 00845819006399

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

Description

Kit Packs Assembled from Non-Sterile Capped Product: 1 eaches of Anterior Chamber Cannula, 27g x 7/8”, 4mm Bend (GTIN: 00845819001455) 1 eaches of A/C Washout Cannula, 19g x 1”, 8mm Bend, Flattened (GTIN: 00845819001592) 1 eaches of Hydrodissection Cannula, 27g x 3/4", 1mm Bend (GTIN: 00845819001530) 1 eaches of Capsulorhexis Cystotome, Formed, 27g x 5/8”, 90 degree Tip (GTIN: 00845819004876) 1 eaches of Hydrodissection Cannula, 25g x 7/8", 8mm Bend (GTIN: 00845819001516)

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

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.