577nm Heine Omega 500 IO with integrated adaptor

GUDID 03700542625392

577nm Heine Omega 500 Indirect Ophthalmoscope with integrated adaptor

QUANTEL MEDICAL

Indirect binocular laser ophthalmoscope
Primary Device ID03700542625392
NIH Device Record Key3f0f2079-892e-4a49-9692-9b34e0070152
Commercial Distribution StatusIn Commercial Distribution
Brand Name577nm Heine Omega 500 IO with integrated adaptor
Version Model NumberIOH577
Company DUNS738574953
Company NameQUANTEL MEDICAL
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+33(0)473745745
Emailcontact@quantel-medical.fr
Phone+33(0)473745745
Emailcontact@quantel-medical.fr
Phone+33(0)473745745
Emailcontact@quantel-medical.fr
Phone+33(0)473745745
Emailcontact@quantel-medical.fr
Phone+33(0)473745745
Emailcontact@quantel-medical.fr
Phone+33(0)473745745
Emailcontact@quantel-medical.fr
Phone+33(0)473745745
Emailcontact@quantel-medical.fr
Phone+33(0)473745745
Emailcontact@quantel-medical.fr
Phone+33(0)473745745
Emailcontact@quantel-medical.fr
Phone+33(0)473745745
Emailcontact@quantel-medical.fr
Phone+33(0)473745745
Emailcontact@quantel-medical.fr
Phone+33(0)473745745
Emailcontact@quantel-medical.fr
Phone+33(0)473745745
Emailcontact@quantel-medical.fr
Phone+33(0)473745745
Emailcontact@quantel-medical.fr
Phone+33(0)473745745
Emailcontact@quantel-medical.fr
Phone+33(0)473745745
Emailcontact@quantel-medical.fr

Device Identifiers

Device Issuing AgencyDevice ID
GS103700542625392 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQFLaser, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-02-19
Device Publish Date2016-09-23

Devices Manufactured by QUANTEL MEDICAL

03700542625569 - VITRA 2 2022-01-06 The VITRA 2 is a laser system which emits a treatment beam at 532 nm and is intended for use in photocoagulation of ocular tissu
03700542625613 - VITRA 8102022-01-06 The Vitra 810 is a laser system which emits a treatment beam at 810 nm and is intended for use in photocoagulation of ocular tis
03700542625927 - EASYRET2021-10-27 The laser (577 nm Fiber Techology Laser SingleSpot, MultiSpot and Subliminal mode and Slit Lamp Zeiss mode) is a photocoagulator
03700542625132 - VITRA2021-04-21 Ophthalmic Laser Photocoagulator 532nm MonoSpot Laser Retinal Photocoagulation
03700542625286 - SUPRA2021-04-21 532nm Ophthalmic Laser System used for Retinal Photocoagulation
03700542625316 - SUPRA 577Y2021-04-21 577nm Ophthalmic Laser System used for Retinal Photocoagulation
03700542625415 - VITRA MULTISPOT2021-04-21 532nm Multispot Laser Retinal Photocoagulation
03700542625484 - EASYRET2021-04-21 577nm Fiber Technology Laser SingleSpot, MultiSpot and SubLiminal mode

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