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510(k) Data Aggregation
K Number
K213800Device Name
Artiglass NRFitTM Tip L.O.R. Glass Syringes
Manufacturer
Artiglass Srl
Date Cleared
2022-05-19
(164 days)
Product Code
QEH, FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Artiglass Srl
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Artiglass NRFit tip Glass Syringe is intended for use, in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the Loss of Resistance technique as explained in standard textbooks. These syringes are not intended for injection or aspiration.
Device Description
The Artiglass NRFit TM tip Glass Syringes provided not sterile with ISO 80369-6 (NRFit™) compliant fittings. They are available in 5mL and 10mL, lock and slip configurations and 5mL and 10mL lock configurations. The NRFit™ tips allow for connections of neuraxial specific applications while reducing the likelihood of misconnections to non-neuraxial devices. The syringe assembly consists of a borosilicate neutral with a graduated scale in milliliters (mL), a borosilicate neutral glass plunger and a nickel-plated brass tip. The plunger rod is amber colored to designate a device intended to only connect to ISO 80369-6 compatible devices such as spinal or epidural needles.
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K Number
K122416Device Name
ARTIGLASS L. O.R. GLASS SYRINGE
Manufacturer
ARTIGLASS SRL
Date Cleared
2013-05-03
(268 days)
Product Code
FMF, ART
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
ARTIGLASS SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Artiglass LOR Glass Syringe is intended for use, in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the Loss of Resistance technique as explained in standard medical textbooks. These syringes are not intended for injection or aspiration.
Device Description
Artiglass L.O.R. Glass Syringe is glass syringe similar to that of a standard piston syringe. It is intended for use in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the Loss of Resistance technique. The Artiglass L.O.R. Glass Syringe is provided not sterile, in bulk form to other manufacturers as part of an epidural insertion trays as a component to the epidural kit. The syringe may be sterilized before use and it can be re-sterilized via Autoclave. Artiglass L.O.R. Glass Syringe is intended to be used only by qualified personnel. This syringe is not intended for injection or aspiration. The Artiglass L.O.R. Glass Syringe is available in volume of 5ml and 10 ml.
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