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510(k) Data Aggregation
K Number
K223208Device Name
Safety Lancet
Manufacturer
Suzhou Zhenwu Medical Co., Ltd.
Date Cleared
2023-02-10
(116 days)
Product Code
FMK
Regulation Number
878.4850Why did this record match?
Applicant Name (Manufacturer) :
Suzhou Zhenwu Medical Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The safety lancet is intended for capillary blood sampling.
Device Description
The safety lancet consists of needle core, protective cap, plug, trigger, spring, outer case and end cap. The sterile part of the safety lancet is the needle tip. The sterile barrier is the needle sleeve and sterilized to a SAL of 10^-6 by radiation sterilization. It is intended for single use only. The shelf-life of the product is 5 years. The safety lancet is intended for capillary blood sampling. The device was designed to minimize the risk from accidental needle sticks with a used needle by application of a sharp injury prevention feature. The needle tip back into the safety lancet body automatically after launch and cannot be reused. The safety lancet can be disposed safely.
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