AUTO CHART PROJECTOR ACP-8

GUDID 04562123289206

TOPCON CORPORATION

Visual acuity projector
Primary Device ID04562123289206
NIH Device Record Key857e7319-2921-44de-9e95-453a8a8af11e
Commercial Distribution StatusIn Commercial Distribution
Brand NameAUTO CHART PROJECTOR ACP-8
Version Model NumberACP-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
GS104562123289206 [Primary]

FDA Product Code

HOSProjector, 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

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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

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