REICHERT, INC.

Address:3362 Walden Ave,DEPEW,NY,14043,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

Tonometer, Ac-Powered (HKX) (6) Tonometer, Manual (HKY) (2) Biomicroscope, Slit-Lamp, Ac-Powered (HJO) (1) System, Imaging, Pulsed Echo, Ultrasonic (IYO) (1)

Premarket Exempt

Clear

Model 30 Pneumatonometer - 00812559010979 Catalog Number :

Device Description : AC powered contact tonometer intended for the measurement of intraocular pressu AC powered contact tonometer intended for the measurement of intraocular pressure (IOP). The device is indicated for use as a screening /monitoring tool for glaucoma or when increased IOP is suspected.

Device Class : 2

Duns Number: 126650253

Premarket Exempt : No

Product Code : HKX

Prescription Use : Yes

Device Count : 1

Reichert® 7CR Auto Tonometer - 00812559011020 Catalog Number :

Device Description : AC -powered non-contact tonometer intended to measure the intraocular pressure o AC -powered non-contact tonometer intended to measure the intraocular pressure of the eye, taking into consideration the biomechanical response of the cornea. An air puff is used to momentarily flatten a patient's cornea during the measurement.

Device Class : 2

Duns Number: 126650253

Premarket Exempt : No

Product Code : HKX

Prescription Use : Yes

Device Count : 1

iPac® Pachymeter - 00812559011228 Catalog Number :

Device Description : Handheld, battery-powered, ultrasound device intended to measure the thicknes Handheld, battery-powered, ultrasound device intended to measure the thickness of the cornea. The device tip is touched to a patient's eye during the measurement.

Device Class : 2

Duns Number: 126650253

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

Xcel® 455 Slit Lamp - 00812559011297 Catalog Number :

Device Description : AC powered biomicroscope that projects light into a patient's eye. The device AC powered biomicroscope that projects light into a patient's eye. The device is intended for use in examining the anterior segment of the eye, from the corneal epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma, which affect the structural properties of the anterior segment of the eye.

Device Class : 2

Duns Number: 126650253

Premarket Exempt : No

Product Code : HJO

Prescription Use : Yes

Device Count : 1

Ocular Response Analyzer® G3 - 00812559011976 Catalog Number :

Device Description : AC-powered, non-contact tonometer intended to measure the intraocular pressure o AC-powered, non-contact tonometer intended to measure the intraocular pressure of the eye and the biomechanical response of the cornea for the purpose of aiding in the diagnosis and monitoring of glaucoma. An air puff is used to momentarily flatten a patient's cornea during the measurement.

Device Class : 2

Duns Number: 126650253

Premarket Exempt : No

Product Code : HKX

Prescription Use : Yes

Device Count : 1

Ocu-Film + - 00812559012089 Catalog Number :

Device Description : Single use tonometer tip cover used with Tono-Pen tonometers. Used to protect t Single use tonometer tip cover used with Tono-Pen tonometers. Used to protect the transducer from dust and fluids, and helps protect patients from risk of cross-contamination.

Device Class : 2

Duns Number: 126650253

Premarket Exempt : No

Product Code : HKY

Prescription Use : Yes

Device Count : 1

Ocu-Film + - 00812559012096 Catalog Number :

Device Class : 2

Duns Number: 126650253

Premarket Exempt : No

Product Code : HKY

Prescription Use : Yes

Device Count : 1

Model 30™ Tip and Membrane Assembly for Pneumatonometer - 00812559012164 Catalog Number :

Device Description : One (1) replacement tip and membrane assembly that attaches to the Model 30 Pneu One (1) replacement tip and membrane assembly that attaches to the Model 30 Pneumatonometer probe. Probe tip touches a patient's cornea during the measurement.

Device Class : 2

Duns Number: 126650253

Premarket Exempt : No

Product Code : HKX

Prescription Use : Yes

Device Count : 1

Model 30™ Tip and Membrane Assembly for Pneumatonometer - 00812559012171 Catalog Number :

Device Description : Three (3) replacement tip and membrane assemblies that attach to the Model 30 Pn Three (3) replacement tip and membrane assemblies that attach to the Model 30 Pneumatonometer probe. Probe tip touches a patient's cornea during the measurement.

Device Class : 2

Duns Number: 126650253

Premarket Exempt : No

Product Code : HKX

Prescription Use : Yes

Device Count : 1

Model 30™ Tip and Membrane Assembly for Pneumatonometer - 00812559012188 Catalog Number :

Device Description : Ten (10) replacement tip and membrane assemblies that attach to the Model 30 Pne Ten (10) replacement tip and membrane assemblies that attach to the Model 30 Pneumatonometer probe. Probe tip touches a patient's cornea during the measurement.

Device Class : 2

Duns Number: 126650253

Premarket Exempt : No

Product Code : HKX

Prescription Use : Yes

Device Count : 1

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