KR-1W Viewer

GUDID 04560126266071

TOPCON CORPORATION

Automated ophthalmic refractometer
Primary Device ID04560126266071
NIH Device Record Keyeb3c3275-56bc-41e5-ae9c-78af544b5bcb
Commercial Distribution StatusIn Commercial Distribution
Brand NameKR-1W Viewer
Version Model NumberKR-1W Viewer
Company DUNS690542881
Company NameTOPCON CORPORATION
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 Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104560126266071 [Primary]

FDA Product Code

HKORefractometer, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-08
Device Publish Date2022-08-31

Devices Manufactured by TOPCON CORPORATION

04571130282773 - REFRACTION SYSTEM Chronos2024-08-09
04571130283350 - AUTO KERATO-REFRACTOMETER KR-8002024-05-17
04571130283374 - AUTO REFRACTOMETER RM-8002024-05-17
04562123288384 - COMPUTERIZED LENSMETER CL-3002023-12-27
04562123288391 - COMPUTERIZED LENSMETER CL-3002023-12-27
04560126268198 - Chinrest CRX-1000 for REFRACTION SYSTEM Chronos2023-11-24
04560126264640 - INFRARED COMMUNICATION UNIT2022-09-08
04560126266071 - KR-1W Viewer2022-09-08
04560126266071 - KR-1W Viewer2022-09-08

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