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0.9% Sodium Chloride Flush Syringes are intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacturer for the appropriate device.

The new device, the subject of this 510(k), consists of a 20 mL, non-sterile plastic syringe filled with 20 mL of 0.9% Sodium Chloride Flush Solution USP that is terminally sterilized. The new devine is starle on the outside and has a sterile fluid path. The Sterility Assurance Level (SAL) is 10°. The syringe may be used on a sterile field if packaging is not damaged and aseptic technique is used. This is a ningle use device. The solution contains no preservatives, or antimicrobial agents. No plasticizers, additives, crosslink agents, reagents, colorants, inks, adhesives, surfactants, detergents, used during the manufacture of the syringes. The 20mL filled with 0.9% Sodium Chloride Flush Solution in a 20mL syringe is the only model which is subject to this 510(k). Other models previously cleared under 510K (K120836) consists of a non-sterile plastic 12 cc syringe filled with 3 mL, 5 mL, or 10 mL of 0.9% Sodium Chloride Flush Solution that is terminal sterilized.

0.9% Sodium Chloride Flush Syringes are intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacturer for the appropriate device.

The Predicate Device, 510(k) Number: K111034, cleared on July14, 2011 consists of a plastic syringe filled with 0.9% Sodium Chloride Solution that is terminally sterilized. The predicate syringe is fluid path sterile with a Sterility Assurance Level (SAL) of 10⁻⁶. This is a single use device packaged in a dust cover. The Modified Device, the subject of this 510 (k), consists of a plastic syringe filled with 0.9% Sodium Chloride Solution that is terminally sterilized. The modified device has a sterile exterior in addition to the sterility of the fluid, fluid path and the exterior of the device. The package that maintains the sterility of the modified device has a Sterility Assurance Level (SAL) is 10⁻⁶. This is a single use device. Technical Data: The technical characteristics of the syringe for the modified device do not differ from those of the currently marketed predicate device. These syringes have the same design, the same functional characteristics, and have the same intended use. The proposed modification involves a change in packaging from the dust cover with a sterile barrier package for use in a sterile field. All other aspects of the syringe design remain the same.

Used in the manufacture of dental prosthetics: crowns, bridges, inlays, and onlays.

Xceram® is a pre-formed material for use by dental laboratories in filling orders/prescriptions for dental prosthetics