Signal Camera

GUDID 06430046260832

Ophthalmic fundus camera

Optomed Oy

Ophthalmic fundus camera
Primary Device ID06430046260832
NIH Device Record Key112bffb3-eb65-4864-8f53-45fa56d29d42
Commercial Distribution StatusIn Commercial Distribution
Brand NameSignal Camera
Version Model Number41001595
Company DUNS401968495
Company NameOptomed Oy
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
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
GS106430046260832 [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 Date2019-10-08
Device Publish Date2019-09-30

Devices Manufactured by Optomed Oy

06430046260658 - Pictor M5WEY4ES2 Volk FN2021-11-23 Volk Pictor Plus full set
06430046260672 - Pictor M5WEY4 Volk FN2021-11-23 Volk Pictor Plus retinal set
06430046260757 - Optomed Aurora full set2019-12-12 Aurora full set including Aurora camera, Aurora Retinal module and Aurora Anterior module.
06430046260795 - Optomed Aurora retinal set2019-12-12 Optomed Aurora retinal set including Aurora camera and Aurora retinal module.
06430046260870 - Volk Pictor Prestige full set2019-12-12 Volk Pictor Prestige full set including Pictor Prestige camera, Pictor Prestige Retina module and Pictor Prestige Anterior modul
06430046260887 - Volk Pictor Prestige retinal set2019-12-12 Volk Pictor Prestige retinal set including Pictor Prestige camera and Pictor Prestige retina module.
06430046260856 - Signal set2019-10-09 Signal product set including Signal Camera.
06430046260832 - Signal Camera2019-10-08Ophthalmic fundus camera
06430046260832 - Signal Camera2019-10-08 Ophthalmic fundus camera

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