Primary Device ID | 09321502060370 |
NIH Device Record Key | 1ea4134d-3156-4849-a70d-1be9c6dfbb17 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Cochlear SoftWear™ Pad |
Version Model Number | P793408 |
Catalog Number | P793408 |
Company DUNS | 750551194 |
Company Name | COCHLEAR LIMITED |
Device Count | 5 |
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 | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 09321502034968 [Primary] |
GS1 | 09321502060370 [Unit of Use] |
MCM | Implant, cochlear |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-03-08 |
Device Publish Date | 2021-02-26 |
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 |