Cochlear™ Nucleus® Contour Advance® Depth Gauge Z179994
GUDID 09321502019439
electrode depth gauge
COCHLEAR LIMITED
Surgical implant template, reusable| Primary Device ID | 09321502019439 |
| NIH Device Record Key | 77848b20-e932-4078-a516-3b7610116825 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cochlear™ Nucleus® Contour Advance® Depth Gauge |
| Version Model Number | Z179994 |
| Catalog Number | Z179994 |
| Company DUNS | 750551194 |
| Company Name | COCHLEAR LIMITED |
| 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com |
Operating and Storage Conditions
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09321502019439 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P970051
FDA Product Code
| LRC | INSTRUMENT, ENT MANUAL SURGICAL |
| MCM | Implant, cochlear |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-29 |
| Device Publish Date | 2020-10-21 |
Devices Manufactured by COCHLEAR LIMITED
| 09321502014557 - Cochlear Surgical Instrument Upgrade Kit | 2024-11-15 |
| 09321502009218 - Nucleus | 2023-11-21 Cochlear Nucleus AOS Forceps for the Contour Advance Electrode |
| 09321502036788 - Nucleus | 2023-11-03 Nucleus Smart App, (iOS) |
| 09321502043205 - Nucleus | 2023-11-03 Custom Sound Suite 5.1 CD |
| 09321502043212 - Nucleus | 2023-11-03 Custom Sound Suite 5.1 Download |
| 09321502043236 - Nucleus | 2023-11-03 Nucleus Smart App |
| 09321502044899 - Cochlear | 2023-11-03 Osia™ Fitting Software 2 |
| 09321502044905 - Cochlear | 2023-11-03 Osia™ Fitting Software 2 |
Trademark Results [Cochlear]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COCHLEAR 79308437 not registered Live/Pending |
Cochlear Limited 2021-02-17 |
 COCHLEAR 79302761 not registered Live/Pending |
Cochlear Limited 2020-12-11 |
 COCHLEAR 79226500 5682597 Live/Registered |
Cochlear Limited 2017-11-30 |
 COCHLEAR 79106109 4615507 Live/Registered |
Cochlear Limited 2011-06-30 |
 COCHLEAR 76656230 3390528 Live/Registered |
COCHLEAR LIMITED 2006-03-03 |
 COCHLEAR 76608815 3175621 Live/Registered |
Cochlear Limited 2004-08-26 |
 COCHLEAR 76583999 3502096 Live/Registered |
COCHLEAR LIMITED 2004-03-30 |
 COCHLEAR 76583996 3502095 Dead/Cancelled |
COCHLEAR LIMITED 2004-03-30 |
 COCHLEAR 76583995 3200044 Live/Registered |
COCHLEAR LIMITED 2004-03-30 |
 COCHLEAR 76583960 3767745 Live/Registered |
COCHLEAR LIMITED 2004-03-30 |
 COCHLEAR 74278522 1764350 Dead/Cancelled |
Cochlear Pty. Limited 1992-05-22 |
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