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510(k) Data Aggregation
K Number
K231822Device Name
GOLFF Sterile Anti-Fog Solution
Manufacturer
Batrik Medical Manufacturing Inc.
Date Cleared
2024-02-26
(250 days)
Product Code
OCT
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Batrik Medical Manufacturing Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GOLFF Sterile Anti-Fog Solution is a single-use, medical device, anti-fog solution used by hospital staff to apply on lenses of endoscopic and laparoscopic cameras. The solution is provided in an easy-to-squeeze bottle and comes with an adhesive-backed sponge for secure placement.
Device Description
GOLFF Sterile Anti-Fog Solution is used to prevent fogging on endoscopic lenses. It ensures clearer vision and avoids unnecessary interruptions during surgery. It also comes with an adhesive-backed sponge, for secure placement, which is also radio-opaque and not made with natural rubber latex. The product is available under reference code GOLFF-R1.
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