FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Argus ll Operating Room Coil
DI: 00856264005387
·
Model: 012103-003
·
Second Sight Medical Products, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Argus ll Operating Room Coil
- Primary DI
- 00856264005387
- Version / Model
- 012103-003
- Catalog Number
- 012103
- 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
- dfa6440d-5ddd-4883-bad1-a20a3c23db42
- Distribution End Date
- 2023-03-31
Device Description
The operating room coil is used during surgery in replacement of the glasses. A telemetry coil and radio-frequency system are mounted on the device to provide communication between the implant and the VPU during surgery.
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 |
|---|---|---|---|---|
| 58522 | Retinal prosthesis system implantation test coil | A radio-frequency coil that is a component of a retinal prosthesis system designed for intraoperative testing of the implant. Typically it is used in the operating room (OR) by a surgeon or other healthcare personnel. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00856264005387 | GS1 |
Customer Contacts
- Phone
- 818-833-5023
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| H110002 | 003 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 32 – 113 Degrees Fahrenheit