RETINAL CAMERA TRC-50DX

GUDID 04562123288278

TOPCON CORPORATION

Ophthalmic fundus camera
Primary Device ID04562123288278
NIH Device Record Keyba253e4c-7aaa-4717-9177-3b0e377868e8
Commercial Distribution StatusIn Commercial Distribution
Brand NameRETINAL CAMERA TRC-50DX
Version Model NumberTRC-50DX
Company DUNS690542881
Company NameTOPCON CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
GS104562123288278 [Primary]

FDA Product Code

HKICamera, ophthalmic, ac-powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-19

On-Brand Devices [RETINAL CAMERA TRC-50DX]

04562123288278TRC-50DX
04571130282643TRC-50DX
04571130282636TRC-50DX

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