RETINAL CAMERA TRC-50DX

GUDID 04571130282636

TOPCON CORPORATION

Ophthalmic fundus camera
Primary Device ID04571130282636
NIH Device Record Key25a3c6f6-6a73-4b07-b8c0-93c09a6026c4
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
GS104571130282636 [Primary]

FDA Product Code

HKICamera, ophthalmic, ac-powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-30
Device Publish Date2021-08-20

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

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

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