FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Argus ll Retinal Implant Kit
DI: 00856264005318
·
Model: 011014-004-K
·
Second Sight Medical Products, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Argus ll Retinal Implant Kit
- Primary DI
- 00856264005318
- Version / Model
- 011014-004-K
- Catalog Number
- 011014-K
- Company Name
- Second Sight Medical Products, Inc.
- Labeler DUNS
- 086470742
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-05-06
- Public Version
- 4
- Public Version Date
- 2023-05-18
- Public Version Status
- Update
- Public Device Record Key
- dc8ec023-8144-4686-9d08-2715274ff746
- Distribution End Date
- 2023-03-31
Device Description
The retinal prosthesis implant is responsible for receiving information from the external components of the system and electrically stimulating the retina to induce visual perception.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NBF | Prosthesis,Retinal | Unknown | f |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58520 | Video-camera epiretinal prosthesis system orbital implant | A sterile implantable component of a video-camera epiretinal prosthesis system designed to be implanted around and inside the eye for neural stimulation of the retina via an electrode array that is attached to the retina with a retinal tack. It consists of an electronics case, an implant coil, an epiretinal electrode array, and a scleral band, and is powered and receives stimulation commands from a visual processing unit which processes the image from the camera mounted on the spectacles and transforms it into electrical stimulation patterns. The power and commands are transmitted wirelessly to the implant from a coil on the spectacles. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00856264005318 | GS1 |
Customer Contacts
- Phone
- 818-833-5027
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| H110002 | 004 |