HiRes 90K™ Surgical Tool Kit
GUDID 07630016809996
Advanced Bionics AG
Cochlear implant system| Primary Device ID | 07630016809996 |
| NIH Device Record Key | d068b3f1-1aa5-4d56-b4d3-fd08c308009d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HiRes 90K™ Surgical Tool Kit |
| Version Model Number | CI-4500 |
| 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 | +1(661)362-1400 |
| xxx@xxx.xxx | |
| Phone | +1(661)362-1400 |
| xxx@xxx.xxx | |
| Phone | +1(661)362-1400 |
| xxx@xxx.xxx | |
| Phone | +1(661)362-1400 |
| xxx@xxx.xxx | |
| Phone | +1(661)362-1400 |
| xxx@xxx.xxx | |
| Phone | +1(661)362-1400 |
| xxx@xxx.xxx | |
| Phone | +1(661)362-1400 |
| xxx@xxx.xxx | |
| Phone | +1(661)362-1400 |
| xxx@xxx.xxx | |
| Phone | +1(661)362-1400 |
| xxx@xxx.xxx | |
| Phone | +1(661)362-1400 |
| xxx@xxx.xxx | |
| Phone | +1(661)362-1400 |
| xxx@xxx.xxx | |
| Phone | +1(661)362-1400 |
| xxx@xxx.xxx | |
| Phone | +1(661)362-1400 |
| xxx@xxx.xxx | |
| Phone | +1(661)362-1400 |
| xxx@xxx.xxx | |
| Phone | +1(661)362-1400 |
| xxx@xxx.xxx | |
| Phone | +1(661)362-1400 |
| xxx@xxx.xxx | |
| Phone | +1(661)362-1400 |
| xxx@xxx.xxx | |
| Phone | +1(661)362-1400 |
| xxx@xxx.xxx | |
| Phone | +1(661)362-1400 |
| xxx@xxx.xxx | |
| Phone | +1(661)362-1400 |
| xxx@xxx.xxx | |
| Phone | +1(661)362-1400 |
| xxx@xxx.xxx | |
| Phone | +1(661)362-1400 |
| xxx@xxx.xxx | |
| Phone | +1(661)362-1400 |
| xxx@xxx.xxx | |
| Phone | +1(661)362-1400 |
| xxx@xxx.xxx | |
| Phone | +1(661)362-1400 |
| xxx@xxx.xxx | |
| Phone | +1(661)362-1400 |
| xxx@xxx.xxx | |
| Phone | +1(661)362-1400 |
| xxx@xxx.xxx | |
| Phone | +1(661)362-1400 |
| xxx@xxx.xxx | |
| Phone | +1(661)362-1400 |
| xxx@xxx.xxx | |
| Phone | +1(661)362-1400 |
| xxx@xxx.xxx |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07630016809996 [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 |
[07630016809996]
Moist Heat or Steam Sterilization
[07630016809996]
Moist Heat or Steam Sterilization
[07630016809996]
Moist Heat or Steam Sterilization
[07630016809996]
Moist Heat or Steam Sterilization
[07630016809996]
Moist Heat or Steam Sterilization
[07630016809996]
Moist Heat or Steam Sterilization
[07630016809996]
Moist Heat or Steam Sterilization
[07630016809996]
Moist Heat or Steam Sterilization
[07630016809996]
Moist Heat or Steam Sterilization
[07630016809996]
Moist Heat or Steam Sterilization
[07630016809996]
Moist Heat or Steam Sterilization
[07630016809996]
Moist Heat or Steam Sterilization
[07630016809996]
Moist Heat or Steam Sterilization
[07630016809996]
Moist Heat or Steam Sterilization
[07630016809996]
Moist Heat or Steam Sterilization
[07630016809996]
Moist Heat or Steam Sterilization
[07630016809996]
Moist Heat or Steam Sterilization
[07630016809996]
Moist Heat or Steam Sterilization
[07630016809996]
Moist Heat or Steam Sterilization
[07630016809996]
Moist Heat or Steam Sterilization
[07630016809996]
Moist Heat or Steam Sterilization
[07630016809996]
Moist Heat or Steam Sterilization
[07630016809996]
Moist Heat or Steam Sterilization
[07630016809996]
Moist Heat or Steam Sterilization
[07630016809996]
Moist Heat or Steam Sterilization
[07630016809996]
Moist Heat or Steam Sterilization
[07630016809996]
Moist Heat or Steam Sterilization
[07630016809996]
Moist Heat or Steam Sterilization
[07630016809996]
Moist Heat or Steam Sterilization
[07630016809996]
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 | 2015-10-08 |
Devices Manufactured by Advanced Bionics AG
| 07630016894015 - M Standard battery | 2024-03-20 |
| 07630016894022 - M Standard battery | 2024-03-20 Precious pink |
| 07630016894039 - M Standard battery | 2024-03-20 Blue ocean |
| 07630016894046 - M Standard battery | 2024-03-20 Majesty purple |
| 07630016875144 - 3D Magnet | 2022-04-08 Max |
| 07630016875557 - 3D Headpiece Magnet Kit | 2022-04-08 |
| 07630016875625 - 3D Magnet | 2022-04-08 Plus |
| 07630016871801 - UHP 3D | 2021-10-19 |
Trademark Results [HiRes 90K]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HIRES 90K 78174451 2872973 Live/Registered |
ADVANCED BIONICS AG 2002-10-15 |
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