Ocular Response Analyzer® G3 - AC-powered, non-contact tonometer intended to - REICHERT, INC.

Duns Number:126650253

Device Description: AC-powered, non-contact tonometer intended to measure the intraocular pressure of the eye 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.

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More Product Details

Catalog Number

-

Brand Name

Ocular Response Analyzer® G3

Version/Model Number

16170

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

HKX

Product Code Name

Tonometer, Ac-Powered

Device Record Status

Public Device Record Key

5512351b-3aa9-459b-a2bb-4c5a0139774a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"REICHERT, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 22