HiFocus™ Mid-Scala Electrode Instrument Kit
GUDID 07630016850554
Advanced Bionics AG
Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system Cochlear implant system| Primary Device ID | 07630016850554 |
| NIH Device Record Key | 21311691-f3d9-4139-9b8f-b365cb9fd4d0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HiFocus™ Mid-Scala Electrode Instrument Kit |
| Version Model Number | CI-4508 |
| Company DUNS | 485262658 |
| Company Name | Advanced Bionics AG |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx | |
| Phone | (661)362-1400 |
| xxx@xxx.xxx |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07630016850554 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P960058
FDA Product Code
| MCM | Implant, Cochlear |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
[07630016850554]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-01-26 |
On-Brand Devices [HiFocus™ Mid-Scala Electrode Instrument Kit]
| 07630016850554 | CI-4508 |
| 07630016815249 | CI-4508 |
Trademark Results [HiFocus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HIFOCUS 78774068 3747825 Live/Registered |
KJELLBERG-STIFTUNG 2005-12-15 |
 HIFOCUS 75631254 2427427 Live/Registered |
ADVANCED BIONICS AG 1999-02-01 |
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