FDA UDI
In Commercial Distribution
🇺🇸 United States
HiRes™ Ultra 3D CI HiFocus™ MS Electrode
DI: 07630016877995
·
Model: CI-1601-04
·
Advanced Bionics AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HiRes™ Ultra 3D CI HiFocus™ MS Electrode
- Primary DI
- 07630016877995
- Version / Model
- CI-1601-04
- Company Name
- Advanced Bionics AG
- Labeler DUNS
- 485262658
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-01-21
- Public Version
- 5
- Public Version Date
- 2024-02-22
- Public Version Status
- Update
- Public Device Record Key
- 83be2162-42ca-4f0f-81cf-18d74a6fa1da
- Distribution End Date
- 2024-05-26
Device Characteristics
- Single Use
- Yes
- 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 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 |
|---|---|---|---|---|
| MCM | Implant, Cochlear | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47373 | Cochlear implant system electrode array assembly | The implantable portion of a cochlear implant system [cochlear implant (CI)] that typically consists of an electrically-powered electrode array surgically implanted in one cochlea, and a receiver-stimulator implanted in the skull near the ear and connected to the electrode array; it does not elute a drug. Electrical signals are transmitted from the external portion of the device to the receiver-stimulator and ultimately to the cochlea, via the electrode array, for the partial restoration of auditory sensation in a severely/profoundly deaf person. Dedicated implantation instruments may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07630016877995 | GS1 |
Customer Contacts
- Phone
- +1(661)362-1400
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P960058 | 144 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 50 Degrees Celsius
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 150 KiloPascal