| Primary Device ID | 00857253006026 |
| NIH Device Record Key | e281b755-bcb1-4101-a99c-72c287af63cc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Phoenix Clinical ICON Control Box |
| Version Model Number | PCI 40-1003 |
| Catalog Number | PCI 40-1003 |
| Company DUNS | 949114925 |
| Company Name | Phoenix Clinical |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 925-462-5000 |
| service@phoenix-clinical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857253006026 [Primary] |
| PJZ | Camera, Ophthalmic, General-Use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-11-18 |
| 00857253006057 - Phoenix ICON Cart System | 2021-12-08 The Phoenix ICON retinal imaging system is a wide-field, handheld, high resolution, real time retinal imaging device. It is inte |
| 00857253006088 - Phoenix ICON GO | 2021-03-01 The Phoenix ICON GO is a portable, hand held, ophthalmic imaging device intended for general opthalmic imaging of the retina, co |
| 00857253006002 - Phoenix Clinical ICON Cart | 2018-03-29 Phoenix Clinical ICON cart assembly. |
| 00857253006026 - Phoenix Clinical ICON Control Box | 2018-03-29Phoenix Clinical ICON Control Box |
| 00857253006026 - Phoenix Clinical ICON Control Box | 2018-03-29 Phoenix Clinical ICON Control Box |
| 00857253006040 - Phoenix Clinical ICON | 2018-03-29 The ICON is a wide-field high-resolution retinal imaging system optimized for pediatric patients to age 18. The image is capture |
| 00857253006064 - Phoenix Clinical White Light Module | 2018-03-29 White light module for the Phoenix Clinical ICON retinal imaging system. |