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510(k) Data Aggregation
Device Name
Safety lancet (XXXVII)Manufacturer
Date Cleared
2026-03-31
(68 days)
Product Code
Regulation Number
878.4850Type
TraditionalAge Range
All
Reference & Predicate Devices
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The safety lancet is intended for capillary blood sampling.
Device Description
The safety lancet is single use medical device, which is designed to collect capillary blood sample.
The intended users include Healthcare personnel, patients and lay persons.
Model XXXVII, the safety lancets consist of needle core, button, housing, ring and spring. 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.
AI/ML Overview
N/A
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