FDA UDI
In Commercial Distribution
🇺🇸 United States
Argus II Video Processing Unit (VPU)
DI: 00850052743000
·
Model: 013003-006
·
CORTIGENT, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Argus II Video Processing Unit (VPU)
- Primary DI
- 00850052743000
- Version / Model
- 013003-006
- Catalog Number
- 013003
- Company Name
- CORTIGENT, INC.
- Labeler DUNS
- 118946135
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-29
- Public Version
- 1
- Public Version Date
- 2023-07-07
- Public Version Status
- New
- Public Device Record Key
- 6e429628-6cae-48b2-8740-2811d327f7bf
Device Description
The 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.
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| 58523 | Video-camera epiretinal prosthesis system visual processing unit | A battery-powered, body-worn component of a video-camera epiretinal prosthesis system designed to convert video images captured by the system spectacles camera into electrical stimulation commands, which are relayed to the system implant via the spectacles. It is connected to the spectacles by a cable. It also typically collects data on the system function, which can be monitored by a clinician during treatment. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850052743000 | GS1 | ||||
| Previous | 00856264005714 | GS1 |
Customer Contacts
- Phone
- 18188335027
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| H110002 | 018 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 32 – 113 Degrees Fahrenheit