| Primary Device ID | 09321502030434 | 
| NIH Device Record Key | 3678bdda-04da-439f-b2d9-591bbfece747 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Field Bone-Anchored Drill Kit | 
| Version Model Number | 91053R | 
| Catalog Number | 91053R | 
| Company DUNS | 130866817 | 
| Company Name | Cochlear Americas Corporation | 
| 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 | false | 
| Serial Number | true | 
| 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 | 
| 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 Issuing Agency | Device ID | 
|---|---|
| GS1 | 09321502030434 [Primary] | 
| LXB | Hearing aid, bone conduction | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2023-07-04 | 
| Device Publish Date | 2023-06-26 | 
| 09321502074117 - BAHA FITTING SOFTWARE 5 CD | 2024-01-11 | 
| 09321502074124 - BAHA FITTING SOFTWARE 6 CD | 2024-01-11 | 
| 09321502074131 - OSIA FITTING SOFTWARE 2 CD | 2024-01-11 | 
| 09321502074148 - CUSTOM SOUND PRO 7.0 CD | 2024-01-11 | 
| 09321502030434 - Field Bone-Anchored Drill Kit | 2023-07-04 | 
| 09321502030434 - Field Bone-Anchored Drill Kit | 2023-07-04 | 
| 09321502070690 - Rental Bone-Anchored Drill Kit | 2023-07-04 |