RetiCapture

GUDID 08800023201017

ILOODA.CO.,LTD

Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera Ophthalmic fundus camera
Primary Device ID08800023201017
NIH Device Record Key7195052a-cfeb-4994-ae85-44e4da6caeda
Commercial Distribution StatusIn Commercial Distribution
Brand NameRetiCapture
Version Model NumberRetiCapture
Company DUNS631129749
Company NameILOODA.CO.,LTD
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800023201017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2022-04-13
Device Publish Date2022-04-05

Devices Manufactured by ILOODA.CO.,LTD

08800023200942 - Secret DUO Main Unit2023-09-07
08800023200959 - Secret DUO Standard Handpiece2023-09-07
08800023201239 - Secret DUO Bigger Handpiece2023-09-07
08800023201390 - Secret DUO Laser Handpiece2023-09-07
08800023202168 - reepot Main Unit2023-09-07
08800023202175 - reepot Handpiece2023-09-07
08800023200218 - VIKINI Main Unit2023-06-19
08800023200225 - VIKINI Laser H/P2023-06-19 DET Laser H/P

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