PRISM COMPENSATOR for LENSMETER LM-8

GUDID 04562123280531

TOPCON CORPORATION

Manually-adjusted lensmeter, line-powered
Primary Device ID04562123280531
NIH Device Record Keye47d325b-c121-4feb-a9e9-20de28525169
Commercial Distribution StatusIn Commercial Distribution
Brand NamePRISM COMPENSATOR for LENSMETER LM-8
Version Model NumberPRISM COMPENSATOR for LENSMETER LM-8
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
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
GS104562123280531 [Primary]

FDA Product Code

HLMInstrument, Measuring, Lens, Ac-Powered

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

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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

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