Ocular Response Analyzer® G3

GUDID 00812559011976

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.

REICHERT, INC.

Ophthalmic tonometer, line-powered
Primary Device ID00812559011976
NIH Device Record Key5512351b-3aa9-459b-a2bb-4c5a0139774a
Commercial Distribution StatusIn Commercial Distribution
Brand NameOcular Response Analyzer® G3
Version Model Number16170
Company DUNS126650253
Company NameREICHERT, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-849-8955
Emailreichert.information@ametek.com
Phone1-888-849-8955
Emailreichert.information@ametek.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100812559011976 [Primary]

FDA Product Code

HKXTonometer, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-22

Devices Manufactured by REICHERT, INC.

00812559010092 - Tono-Pen® XL2018-07-06 Handheld, battery-powered, contact tonometer. Indications for use include measuring intraocular pressure (IOP) for suspected g
00812559010108 - Tono-Pen AVIA®2018-07-06 Handheld, battery-powered contact tonometer. Indications for use include measuring intraocular pressure (IOP) for suspected gla
00812559010115 - Ocu-Film +2018-07-06 Single use tonometer tip cover used with Tono-Pen tonometers. Used to protect the transducer from dust and fluids, and helps pr
00812559010221 - CT210 Contact Tonometer2018-07-06 Non-active, contact applanation tonometer intended to measure intraocular pressure of the eye.
00812559010429 - PT100 Portable Non-Contact Tonometer2018-07-06 Handheld, battery-powered, non-contact tonometer intended to measure the intraocular pressure of the eye. An air puff is used t
00812559010498 - PSL Portable Slit Lamp2018-07-06 Handheld, battery powered, biomicroscope that projects light into a patient’s eye. It is intended for use in eye examinatio
00812559010504 - Xcel® 255 Slit Lamp 2018-07-06 AC powered biomicroscope that projects light into a patient's eye. The device is intended for use in examining the anterior se
00812559010955 - Model 30 Pneumatonometer2018-07-06 AC powered contact tonometer intended for the measurement of intraocular pressure (IOP). The device is indicated for use as a s

Trademark Results [Ocular Response Analyzer]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OCULAR RESPONSE ANALYZER
OCULAR RESPONSE ANALYZER
77112519 3545476 Live/Registered
Reichert, Inc.
2007-02-21

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