Automated Perimeter - The PTS 925W automated perimeter is a diagnostic - OPTOPOL TECHNOLOGY SP Z O O

Duns Number:522052554

Device Description: The PTS 925W automated perimeter is a diagnostic instrument designed for visual field test The PTS 925W automated perimeter is a diagnostic instrument designed for visual field testing. The device is used for early detection of glaucoma, cataract, neurological defects, diplopia, and retinal diseases, including macular degeneration, retinitis pigmentosa, or scintillating scotomas.

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More Product Details

Catalog Number

765-001

Brand Name

Automated Perimeter

Version/Model Number

PTS 925W

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

HPT

Product Code Name

Perimeter, Automatic, Ac-Powered

Device Record Status

Public Device Record Key

8b4dcc58-15a1-4c3d-b518-df147cc73f8e

Public Version Date

August 01, 2022

Public Version Number

2

DI Record Publish Date

March 09, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OPTOPOL TECHNOLOGY SP Z O O" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6