| Primary Device ID | 00850052743000 |
| NIH Device Record Key | 6e429628-6cae-48b2-8740-2811d327f7bf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Argus II Video Processing Unit (VPU) |
| Version Model Number | 013003-006 |
| Catalog Number | 013003 |
| Company DUNS | 118946135 |
| Company Name | CORTIGENT, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | 00850052743000 [Primary] |
| GS1 | 00856264005714 [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 | 2023-07-07 |
| Device Publish Date | 2023-06-29 |
| 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 |
| 00850052743000 - Argus II Video Processing Unit (VPU) | 2023-07-07The VPU is used to process the images from the video camera (on the Glasses) and convert the images into electrical stimulation commands which are transmitted wirelessly to the implant. The VPU is worn by the patient, typically on a belt or a strap. |
| 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 |