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510(k) Data Aggregation
K Number
K200242Device Name
StaClear Syringe
Manufacturer
TriboFilm Research, Inc.
Date Cleared
2020-07-27
(178 days)
Product Code
QLY, FMF, FMI
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
TriboFilm Research, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The StaClear Syringe is intended to inject fluids into, or withdraw fluids from, the body. The StaClear Syringe is indicated for intravitreal use.
Device Description
The StaClear Syringe is a single-use piston syringe consisting of a 0.25 mL graduated barrel, plunger, plunger stopper, needle, needle shield, and plunger cap. The needle is a 31-gauge needle, 5/16in in length, which is permanently attached to the syringe body. It is intended for use by health care professionals for general purpose fluid aspiration/injection. Its operation is manual. The StaClear syringe is single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The StaClear syringe is suitable for ophthalmic use.
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K Number
K071027Device Name
TRIBOGLIDE LUBRICATED SILICONE-FREE SYRINGE
Manufacturer
TRIBOFILM RESEARCH, INC.
Date Cleared
2007-07-20
(100 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
TRIBOFILM RESEARCH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TriboGlide™ Lubricated Silicone-Free Syringe when combined with an appropriate gauge needle is used to inject fluids into, or withdraw fluids from, the body.
Device Description
The TriboGlide™ Silicone-Free Syringes are sterile and disposable (single use) standard polypropylene piston syringes without permanently attached needles. They consist of a polypropylene syringe barrel and plunger. Various syringe sizes include 0.5ml, 1ml, 3ml, 6ml, 10ml, 12ml, 60ml and 140ml. The lubricant used in the TriboGlide syringe is a fluorocarbon based non-silicone lubricant. The TriboGlide™ Silicone-Free Syringes, when combined with an appropriate gauge needle, are used to inject fluids into, and withdraw fluids from, the body.
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