Primary Device ID | 04987669200636 |
NIH Device Record Key | 39e20634-d95f-46d9-90d7-fc35645c10db |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Image filing software NAVIS-EX |
Version Model Number | 1.12 |
Company DUNS | 690635461 |
Company Name | NIDEK CO.,LTD. |
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 | true |
Serial Number | false |
Manufacturing Date | false |
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 | 1-800-223-9044 |
info@nidek.com | |
Phone | 1-800-223-9044 |
info@nidek.com | |
Phone | 1-800-223-9044 |
info@nidek.com | |
Phone | 1-800-223-9044 |
info@nidek.com | |
Phone | 1-800-223-9044 |
info@nidek.com | |
Phone | 1-800-223-9044 |
info@nidek.com | |
Phone | 1-800-223-9044 |
info@nidek.com | |
Phone | 1-800-223-9044 |
info@nidek.com | |
Phone | 1-800-223-9044 |
info@nidek.com | |
Phone | 1-800-223-9044 |
info@nidek.com | |
Phone | 1-800-223-9044 |
info@nidek.com | |
Phone | 1-800-223-9044 |
info@nidek.com | |
Phone | 1-800-223-9044 |
info@nidek.com | |
Phone | 1-800-223-9044 |
info@nidek.com | |
Phone | 1-800-223-9044 |
info@nidek.com | |
Phone | 1-800-223-9044 |
info@nidek.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04987669200636 [Primary] |
NFG | Device, Communications, Images, Ophthalmic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-06-20 |
Device Publish Date | 2023-06-12 |
04987669200018 - A-scan probe | 2023-07-18 It is used to scan axial length with the ultrasonic measurement function which equipped with the OPTICAL BIOMETER AL-Scan. |
04987669200049 - Pachymetry probe (45° fixed type) | 2023-07-18 It is used to scan corneal thickness with the ultrasonic measurement function which equipped with the OPTICAL BIOMETER AL-Scan. |
04987669200070 - A-scan probe | 2023-07-18 It is used to scan axial length with the ultrasonic measurement function which equipped with the ECHOSCAN US-4000. |
04987669200094 - Pachymetry probe | 2023-07-18 It is used to scan corneal thickness with the ultrasonic measurement function which equipped with the ECHOSCAN US-4000. |
04987669200100 - Pachymetry probe (45° fixed type) | 2023-07-18 It is used to scan corneal thickness with the ultrasonic measurement function which equipped with the ECHOSCAN US-4000. |
04987669200117 - A-scan probe | 2023-07-18 It is used to scan axial length with the ultrasonic measurement function which equipped with the ECHOSCAN US-500. |
04987669200780 - IOL-Station | 2023-07-18 The IOL-Station software acquires examination data from the NIDEK Refractive Power / Corneal Analyzer model OPD-Scan III, Optica |
04987669100844 - IOL-Station | 2023-06-20 The IOL-Station software acquires examination data from the NIDEK Refractive Power / Corneal Analyzer model OPD-Scan III, Optica |