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 ID: 00812559011976
• NIH Device Record Key: 5512351b-3aa9-459b-a2bb-4c5a0139774a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ocular Response Analyzer® G3
• Version Model Number: 16170
• Company DUNS: 126650253
• Company Name: REICHERT, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-888-849-8955
• Email: reichert.information@ametek.com
• Phone: 1-888-849-8955
• Email: reichert.information@ametek.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812559011976 [Primary]

FDA Product Code

• HKX: Tonometer, Ac-Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-22

Devices Manufactured by REICHERT, INC.

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• 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 Tonometer: 2018-07-06 Non-active, contact applanation tonometer intended to measure intraocular pressure of the eye.
• 00812559010429 - PT100 Portable Non-Contact Tonometer: 2018-07-06 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 Lamp: 2018-07-06 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 Pneumatonometer: 2018-07-06 AC powered contact tonometer intended for the measurement of intraocular pressure (IOP). The device is indicated for use as a s