RTVue XR Avanti 700-54345-001

GUDID 00858848006728

Ophthalmic Optical Coherence Tomography System with 100/240V Table

OPTOVUE, INC.

Spectral-domain optical coherence tomography system
Primary Device ID00858848006728
NIH Device Record Key1aa91591-ad16-4ec3-8005-c6b281a6f6bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameRTVue XR Avanti
Version Model Number100
Catalog Number700-54345-001
Company DUNS196500461
Company NameOPTOVUE, INC.
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

Customer Support Contacts

Phone866-941-9240
Email[email protected]

Device Identifiers

Device Issuing AgencyDevice ID
GS100858848006728 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HLIOphthalmoscope, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-11
Device Publish Date2020-02-03

On-Brand Devices [RTVue XR Avanti]

00858848006469Ophthalmic Optical Coherence Tomography System with 100/240V Table
00858848006452Ophthalmic Optical Coherence Tomography System with 100/240V Table
00858848006391Ophthalmic Optical Coherence Tomography System w/230 VAC Table
00858848006384Ophthalmic Optical Coherence Tomography System w/120 VAC Table
00858848006346Ophthalmic Optical Coherence Tomography System with 100/240V Table
00858848006674Ophthalmic Optical Coherence Tomography System with 100/240V Table
00858848006704Ophthalmic Optical Coherence Tomography System with 100/240V Table
00858848006728Ophthalmic Optical Coherence Tomography System with 100/240V Table

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