Cochlear™ Slimline™ Coil Z597494
GUDID 09321502036443
6 cm (2 1/2") Grey
COCHLEAR LIMITED
Cochlear implant system coil| Primary Device ID | 09321502036443 |
| NIH Device Record Key | bac4bfc4-bd15-46a5-996b-8524299c8d60 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cochlear™ Slimline™ Coil |
| Version Model Number | Z597494 |
| Catalog Number | Z597494 |
| Company DUNS | 750551194 |
| Company Name | COCHLEAR LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| 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 | 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 | |
| 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 |
Device Dimensions
| Device Size Text, specify | 0 |
| Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6 Centimeter |
| Device Size Text, specify | 0 |
| Length | 6 Centimeter |
Operating and Storage Conditions
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09321502036443 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P970051
FDA Product Code
| MCM | IMPLANT, COCHLEAR |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-08-30 |
| Device Publish Date | 2017-06-28 |
On-Brand Devices [Cochlear™ Slimline™ Coil]
| 09321502036566 | 11 cm (4") Black |
| 09321502036559 | 8 cm (3") Black |
| 09321502036542 | 6 cm (2 1/2") Black |
| 09321502036535 | 11 cm (4") White |
| 09321502036528 | 11 cm (4") Grey |
| 09321502036511 | 11 cm (4") Brown |
| 09321502036504 | 11 cm (4") Sand |
| 09321502036498 | 8 cm (3") White |
| 09321502036481 | 8 cm (3") Grey |
| 09321502036474 | 8 cm (3") Brown |
| 09321502036467 | 8 cm (3") Sand |
| 09321502036450 | 6 cm (2 1/2") White |
| 09321502036443 | 6 cm (2 1/2") Grey |
| 09321502036436 | 6 cm (2 1/2") Brown |
| 09321502036429 | 6 cm (2 1/2") Sand |
| 09321502040389 | 25cm (10") Grey |
| 09321502040372 | 25 cm (10") Brown |
| 09321502040365 | 25 cm (10") White |
| 09321502040358 | 25cm (10") Sand |
| 09321502039611 | 25cm (10") Black |
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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.