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510(k) Data Aggregation
K Number
K222801Device Name
Safety Lancet
Manufacturer
Date Cleared
2023-01-25
(131 days)
Product Code
Regulation Number
878.4850Why did this record match?
Applicant Name (Manufacturer) :
**Sarstedt AG **& CO KG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Safety-Lancets with safety feature are used for single use capillary blood sampling.
Device Description
The Safety Lancet consists of the following components: colorless plastic body, needle holder with needle or blade shaped lancing device, protective cap, carrier device, two springs, and the release button. The release button, the needle holder, and the protective cap are colored according to the variant available. The lancets are offered with different needle or blade shaped lancing devices, different sharpening and penetration depths, and accordingly in different colors. The lancets contain a safety feature. After puncture the needle retracts automatically into the housing to prevent sharps injuries.
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