Primary Device ID | 00858848006452 |
NIH Device Record Key | 044c29e6-61e0-415c-babb-1b5bdff4f86b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | RTVue XR Avanti |
Version Model Number | 100 |
Catalog Number | 700-51134-002 |
Company DUNS | 196500461 |
Company Name | OPTOVUE, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 866-941-9240 |
service@optovue.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00858848006452 [Primary] |
HLI | Ophthalmoscope, Ac-Powered |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2018-10-08 |
Device Publish Date | 2018-09-06 |
00858848006469 | Ophthalmic Optical Coherence Tomography System with 100/240V Table |
00858848006452 | Ophthalmic Optical Coherence Tomography System with 100/240V Table |
00858848006391 | Ophthalmic Optical Coherence Tomography System w/230 VAC Table |
00858848006384 | Ophthalmic Optical Coherence Tomography System w/120 VAC Table |
00858848006346 | Ophthalmic Optical Coherence Tomography System with 100/240V Table |
00858848006674 | Ophthalmic Optical Coherence Tomography System with 100/240V Table |
00858848006704 | Ophthalmic Optical Coherence Tomography System with 100/240V Table |
00858848006728 | Ophthalmic Optical Coherence Tomography System with 100/240V Table |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() RTVUE XR AVANTI 86245168 4969263 Live/Registered |
Optovue, Inc. 2014-04-07 |