| Primary Device ID | 00850052743161 |
| NIH Device Record Key | b86675fd-0736-4949-85c0-839bfdeb46a8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Argus II Operating Room Coil |
| Version Model Number | 012103-003 |
| Catalog Number | 012103 |
| Company DUNS | 118946135 |
| Company Name | CORTIGENT, 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 | 18188335027 |
| customerservice@cortigent.com | |
| Phone | 18188335027 |
| customerservice@cortigent.com | |
| Phone | 18188335027 |
| customerservice@cortigent.com | |
| Phone | 18188335027 |
| customerservice@cortigent.com | |
| Phone | 18188335027 |
| customerservice@cortigent.com | |
| Phone | 18188335027 |
| customerservice@cortigent.com | |
| Phone | 18188335027 |
| customerservice@cortigent.com | |
| Phone | 18188335027 |
| customerservice@cortigent.com | |
| Phone | 18188335027 |
| customerservice@cortigent.com | |
| Phone | 18188335027 |
| customerservice@cortigent.com | |
| Phone | 18188335027 |
| customerservice@cortigent.com | |
| Phone | 18188335027 |
| customerservice@cortigent.com | |
| Phone | 18188335027 |
| customerservice@cortigent.com | |
| Phone | 18188335027 |
| customerservice@cortigent.com | |
| Phone | 18188335027 |
| customerservice@cortigent.com | |
| Phone | 18188335027 |
| customerservice@cortigent.com | |
| Phone | 18188335027 |
| customerservice@cortigent.com |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850052743161 [Primary] |
| GS1 | 00856264005387 [Previous] |
| NBF | Prosthesis, Retinal |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-10 |
| Device Publish Date | 2023-06-30 |
| 00850052743055 - Argus II Communication Adapter (CA) | 2023-07-10 A device which provides data communication and electrical isolation between the Video Processing Unit and the Clinician Programm |
| 00850052743123 - Argus II Glasses, Left Eye, Dark Lenses | 2023-07-10 The Argus II Glasses provide a convenient and discreet way to house the video camera for capturing images and the radio-frequenc |
| 00850052743161 - Argus II Operating Room Coil | 2023-07-10 |
| 00850052743161 - Argus II Operating Room Coil | 2023-07-10 |
| 00850052743000 - Argus II Video Processing Unit (VPU) | 2023-07-07 The VPU is used to process the images from the video camera (on the Glasses) and convert the images into electrical stimulation |
| 00850052743109 - Argus II Glasses - Right Eye - Dark Lenses | 2023-07-07 The Argus II Glasses provide a convenient and discreet way to house the video camera for capturing images and the radio-frequenc |
| 00850052743116 - Argus II Glasses, Right Eye, Clear Lenses | 2023-07-07 The Argus II Glasses provide a convenient and discreet way to house the video camera for capturing images and the radio-frequenc |
| 00850052743130 - Argus II Glasses, Left Eye, Clear Lenses | 2023-07-07 The Argus II Glasses provide a convenient and discreet way to house the video camera for capturing images and the radio-frequenc |