Automated Projection Perimeter

GUDID 05903293141113

The PTS 2000 automated projection perimeter is a diagnostic instrument designed for visual field testing. The device is used for early detection of gl

OPTOPOL TECHNOLOGY SP Z O O

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Primary Device ID05903293141113
NIH Device Record Key48991147-7cae-4e3f-a7ad-aec568c599e7
Commercial Distribution StatusIn Commercial Distribution
Brand NameAutomated Projection Perimeter
Version Model NumberPTS 2000
Company DUNS522052554
Company NameOPTOPOL TECHNOLOGY SP Z O O
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105903293141113 [Primary]

FDA Product Code

HPTPerimeter, Automatic, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-04-09
Device Publish Date2018-03-09

Devices Manufactured by OPTOPOL TECHNOLOGY SP Z O O

05903293141113 - Automated Projection Perimeter2018-04-09The PTS 2000 automated projection perimeter is a diagnostic instrument designed for visual field testing. The device is used for early detection of gl
05903293141113 - Automated Projection Perimeter2018-04-09 The PTS 2000 automated projection perimeter is a diagnostic instrument designed for visual field testing. The device is used for
05903293141120 - Automated Perimeter2018-04-09 The PTS 920 automated perimeter is a diagnostic instrument designed for visual field testing. The device is used for early detec
05903293141137 - Automated Perimeter2018-04-09 The PTS 920BY automated projection perimeter is a diagnostic instrument designed for visual field testing. The device is used fo
05903293141144 - Automated Perimeter2018-04-09 The PTS 925 automated perimeter is a diagnostic instrument designed for visual field testing. The device is used for early detec
05903293141151 - Automated Perimeter2018-04-09 The PTS 925W automated perimeter is a diagnostic instrument designed for visual field testing. The device is used for early dete
05903293141168 - Automated Perimeter2018-04-09 The PTS 925BY automated perimeter is a diagnostic instrument designed for visual field testing. The device is used for early det
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