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510(k) Data Aggregation
K Number
K100551Device Name
ORLOCATE SYSTEM MODEL ORL 100
Manufacturer
HALDOR ADVANCED TECHNOLOGIES LTD
Date Cleared
2010-08-12
(167 days)
Product Code
LWH
Regulation Number
880.2740Why did this record match?
Applicant Name (Manufacturer) :
HALDOR ADVANCED TECHNOLOGIES LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ORLocate™ system is indicated for use in recording and counting the number of RFID-tagged surgical sponges, laparotomy sponges, towels and other tagged items used during surgical procedures in which counting is required. In addition, the product is indicated for providing a non-invasive means of detecting retained RFID-tagged surgical sponges, towels and other tagged items within a surgical site, as an adjunctive detection method to current surgical counting systems and methods.
Device Description
Haldor ORLocate™ system is an RFID system providing a solution that enables the enumeration of sponges and surgical manual instruments, utilizing passive tags for keeping track of the items during surgery and to identify counting problems. In addition, the system provides a non-invasive means of locating retained surgical items within a surgical site. The submission consists of the ORLocate™ system which includes: cart and antennas. Additionaly the submission includes accessories which are: associated single use surgical sponges, gauzes, pads and surgical towels each fitted with a uniquely coded RFID tag and uniquely coded RFID tag used for surgical instruments. The RF frequency the system uses is 13.56 MHz according to ISO 15693. The system supplies also a semi-automatic application to help in counting untagged items, the count information is first entered manually and the calculations are automatic.
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