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510(k) Data Aggregation
K Number
K052725Device Name
PROTECTOR NEEDLE SHEATH PROP
Manufacturer
CERTOL INTERNATIONAL, LLC
Date Cleared
2005-12-28
(90 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
CERTOL INTERNATIONAL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ProTector™ Needle Sheath Prop is a disposable, non-sterile device that can be used to safely uncap and recap needles using a one-handed technique. ProTector™ Needle Sheath Prop facilitates OSHA requirements by reducing the possibility of accidental needle sticks and discourages leaving the needle unsheathed on the tray. The Prop is autoclavable for one-time sterile tray set-up. It holds the cap securely in the ready position.
Device Description
The ProTector™ Needle Sheath Prop is a disposable, non-sterile, one-time use device that can be used to safely uncap and recap needles using a one-handed technique. The ProTector™ facilitates and meets OSHA's Bloodborne Pathogens requirement to promote reduction in accidental needle sticks. Use of the ProTector™ discourages leaving the needle unsheathed on an instrument trav. The device is specifically designed to capture the needle cover/cap and hold it in the ready position. The ProTector™ is manufactured using a premium grade rectangular paper board card. The sheathed needle cap is inserted into the targeted hole up to the cover hub, securing the needle cover firmly in the ProTector™. The targeted hole is designed as a flexible press-fit to accommodate all sizes of needle protector cover up to 3/8" OD which accommodates most needle covers on the market. After the needle and cover is inserted into the ProTector™, it is now in the ready position to be able to safely withdraw the needle. The rectangular shape of the ProTector™ allows the loaded needle cover to be propped on the dental or medical tray.
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