RTVue XR Avanti Scanner 500-50845-002

GUDID 00858848006360

For use with Optovue RTVue XR Avanti Ophthalmic Optical Coherence Tomography System

OPTOVUE, INC.

Spectral-domain optical coherence tomography system
Primary Device ID00858848006360
NIH Device Record Keyb2352dbb-e3a1-4f14-8716-59a0bf01080b
Commercial Distribution StatusIn Commercial Distribution
Brand NameRTVue XR Avanti Scanner
Version Model NumberAvanti Scanner
Catalog Number500-50845-002
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
Emailservice@optovue.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100858848006360 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OBOTomography, Optical Coherence

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-05-15

On-Brand Devices [RTVue XR Avanti Scanner]

00858848006377For use with Optovue RTVue XR Avanti Ophthalmic Optical Coherence Tomography System
00858848006360For use with Optovue RTVue XR Avanti Ophthalmic Optical Coherence Tomography System
00858848006353For use with Optovue RTVue XR Avanti Ophthalmic Optical Coherence Tomography System
00858848006667For use with Optovue RTVue XR Avanti Ophthalmic Optical Coherence Tomography System

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