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510(k) Data Aggregation
K Number
K081821Device Name
D.A.R.T. PRO KIT (D.A.R.T. PRO HANDLE AND X-TRACTOR TIP)
Manufacturer
Date Cleared
2008-09-02
(67 days)
Product Code
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
GLOBAL PATHOGEN SOLUTIONS INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The D.A.R.T. Pro Handle and X-TRACTOR Tip are solely intended for use in the acquisition, removal and storage of darts projected from stun guns and lodged in human tissue and/or clothing. The device is not intended for use as a medical sharps container.
Device Description
The reusable D.A.R.T. Pro Handle and detachable, single-use only X-TRACTOR Tip (including a safety cap) comprise the two components of the device. Each of these components is described generally below.
- D.A.R.T. Pro Handle: A reusable handle component that is uniquely designed for the secure attachment (and removal post-use) of the X-TRACTOR Tip. The D.A.R.T. Pro Handle allows the user to hold, control and position the assembled product as required for stun gun dart acquisition and removal within the X-TRACTOR Tip. The D.A.R.T. Pro Handle includes a switch at the top of the handle to activate an internal LED light source to illuminate the X-TRACTOR Tip to ease device use in darkened environments. The LED light requires only a standard 9-volt battery, which the user can easily replace as needed.
- X-TRACTOR Tip: A single-use, detachable stun gun dart containment tip specifically designed to securely house up to two stun gun darts. In use, the X-TRACTOR Tip is placed over the stun gun dart and advanced to lock the dart into a sliding tip collet. The D.A.R.T. Pro Handle is then pulled to remove the dart. The external button on the tip collet is then pressed to slide the tip collet and secure the removed dart within the X-TRACTOR Tip. Following removal of up to two stun gun darts, the safety cap is press-fit over the X-TRACTOR Tip to securely house the darts within the X-TRACTOR Tip. Once placed, the safety cap cannot be removed from the X-TRACTOR Tip. The capped X-TRACTOR Tip is then removed from the D.A.R.T. Pro Handle, placed within a zip-seal bag, and the zip-seal bag appropriately identified for provision to law enforcement personnel.
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