Tribofilm Research, Inc.

Address:7250 ACC Blvd.,Raleigh,NC,27617,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Ophthalmic Syringe (QLY) (2) Syringe, Piston (FMF) (2) Needle, Hypodermic, Single Lumen (FMI) (1)

Premarket Exempt

Clear

StaClear - B994SC2500 Catalog Number : SC250

Device Description : The StaClear® Syringe is a single-use piston syringe consisting of a 0.25 mL gra The StaClear® Syringe is a single-use piston syringe consisting of a 0.25 mL graduated barrel, plunger, plunger gasket, needle, needle cap, and plunger cap. It is non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The StaClear® Syringe is suitable for ophthalmic use.

Device Class :

Duns Number: 115690369

Premarket Exempt : No

Product Code : QLY, FMF, FMI

Prescription Use : Yes

Device Count : 1

StaClear - B994SC250LS0 Catalog Number :

Device Description : The StaClear Model SC250LS Syringe is a single-use piston syringe consisting of The StaClear Model SC250LS Syringe is a single-use piston syringe consisting of a graduated barrel, plunger, and plunger stopper. It is non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The StaClear Syringe is suitable for ophthalmic use.

Device Class :

Duns Number: 115690369

Premarket Exempt : No

Product Code : QLY, FMF

Prescription Use : Yes

Device Count : 1

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