| Primary Device ID | 04987669200094 | 
| NIH Device Record Key | efcd91e4-bc45-4a8b-88b7-6bac351496d7 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Pachymetry probe | 
| Version Model Number | 14610-0107 | 
| 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 | false | 
| Serial Number | true | 
| 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 | |
| Phone | 1-800-223-9044 | 
| info@nidek.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 04987669200094 [Primary] | 
| ITX | Transducer, Ultrasonic, Diagnostic | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2023-07-18 | 
| Device Publish Date | 2023-07-10 | 
| 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 | 2023-07-18It is used to scan corneal thickness 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 |