FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Argus ll Clinician Programming System
DI: 00856264005394
·
Model: 014003-004-R
·
Second Sight Medical Products, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Argus ll Clinician Programming System
- Primary DI
- 00856264005394
- Version / Model
- 014003-004-R
- Catalog Number
- 014003
- 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
- b7b0a63b-c1c9-42d6-9dd0-9810c14c0a71
- Distribution End Date
- 2023-03-31
Device Description
Laptop computer that is configured with dedicated, PC-based software that, when connected to the Video Processing Unit, enables programming of the electrical stimulation parameters of the implant.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- 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 |
|---|---|---|---|---|
| 58524 | Retinal prosthesis system tester/clinical evaluator | A component of a retinal prosthesis system designed to perform diagnostic tests of the system, measure patient response to stimulation, and configure the system stimulation parameters and video processing strategies for each patient. It consists of laptop computer, dedicated software, and a communication adaptor. It is used in medical facilities and clinical research settings and is operated by a clinician or other healthcare personnel. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00856264005394 | GS1 |
Customer Contacts
- Phone
- 818-833-5027
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| H110002 | 003 |