| Primary Device ID | 10856264005322 |
| NIH Device Record Key | 2ee264eb-f10f-48ea-be96-2b88f310a1c5 |
| Commercial Distribution Discontinuation | 2023-03-31 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Argus II Retinal Prosthesis Retinal Tacks |
| Version Model Number | 011006-001 |
| Catalog Number | 011006 |
| Company DUNS | 086470742 |
| Company Name | Second Sight Medical Products, Inc. |
| Device Count | 2 |
| 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 | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | (818) 833-5027 |
| customerservice@2-sight.com | |
| Phone | (818) 833-5027 |
| customerservice@2-sight.com | |
| Phone | (818) 833-5027 |
| customerservice@2-sight.com | |
| Phone | (818) 833-5027 |
| customerservice@2-sight.com | |
| Phone | (818) 833-5027 |
| customerservice@2-sight.com | |
| Phone | (818) 833-5027 |
| customerservice@2-sight.com | |
| Phone | (818) 833-5027 |
| customerservice@2-sight.com | |
| Phone | (818) 833-5027 |
| customerservice@2-sight.com | |
| Phone | (818) 833-5027 |
| customerservice@2-sight.com | |
| Phone | (818) 833-5027 |
| customerservice@2-sight.com | |
| Phone | (818) 833-5027 |
| customerservice@2-sight.com | |
| Phone | (818) 833-5027 |
| customerservice@2-sight.com | |
| Phone | (818) 833-5027 |
| customerservice@2-sight.com | |
| Phone | (818) 833-5027 |
| customerservice@2-sight.com | |
| Phone | (818) 833-5027 |
| customerservice@2-sight.com | |
| Phone | (818) 833-5027 |
| customerservice@2-sight.com | |
| Phone | (818) 833-5027 |
| customerservice@2-sight.com | |
| Phone | (818) 833-5027 |
| customerservice@2-sight.com |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00856264005325 [Unit of Use] |
| GS1 | 10856264005322 [Primary] |
| NBF | Prosthesis,Retinal |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2023-05-18 |
| Device Publish Date | 2014-12-16 |
| 10856264005322 - Argus II Retinal Prosthesis Retinal Tacks | 2023-05-18The Argus II Retinal Tack is used to affix the electrode array of the Retinal Prosthesis to the retina. |
| 10856264005322 - Argus II Retinal Prosthesis Retinal Tacks | 2023-05-18 The Argus II Retinal Tack is used to affix the electrode array of the Retinal Prosthesis to the retina. |
| 00856264005288 - Argus ll Rentinal Prosthesis Kit, Right Eye | 2018-07-06 The retinal prosthesis implant is responsible for receiving information from the external components of the system and electrica |
| 00856264005295 - Argus ll Retinal Implant Kit, Right Eye | 2018-07-06 The retinal prosthesis implant is responsible for receiving information from the external components of the system and electrica |
| 00856264005301 - Argus ll Retinal Implant Kit | 2018-07-06 The retinal prosthesis implant is responsible for receiving information from the external components of the system and electrica |
| 00856264005318 - Argus ll Retinal Implant Kit | 2018-07-06 The retinal prosthesis implant is responsible for receiving information from the external components of the system and electrica |
| 00856264005332 - Argus ll Video Processing Unit | 2018-07-06 The VPU is used to process the images from the video camera (on the Glasses) and convert the images into electrical stimulation |
| 00856264005349 - Argus ll Glasses | 2018-07-06 The Argus II Glasses provide a convenient and discreet way to house the video camera for capturing images and the radio-frequenc |
| 00856264005356 - Argus ll Glasses | 2018-07-06 The Argus II Glasses provide a convenient and discreet way to house the video camera for capturing images and the radio-frequenc |