Primary Device ID | 05711781001715 |
NIH Device Record Key | 7df7f736-ec2f-4494-bce4-a7679128cfdc |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | OTOSphere By Auditdata |
Version Model Number | OTOSphere |
Company DUNS | 310385849 |
Company Name | Auditdata A/S |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | 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 | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 05711781001715 [Primary] |
EWO | Audiometer |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-08-24 |
05711781004006 - Unity 3 | 2024-10-29 U3HIT Package AD-version US |
05711781002743 - Measure | 2024-09-25 2000-1 Fitting Unit Audiometer SW |
05711781003818 - Unity 4 / Measure | 2024-09-25 |
00571178100316 - Unity 4 | 2024-08-29 2000-1 Fitting Unit Audiometer |
05711781002729 - Unity 4 / Measure | 2024-08-29 2000-1 Fitting Unit Audiometer |
05711781002736 - Unity 4 / Measure | 2024-08-29 2000-1 Fitting Unit Audiometer |
05711781002750 - Unity 4 | 2024-08-29 2000-1 Fitting Unit Audiometer |
05711781002774 - Unity 4 / Measure | 2024-08-29 2000-1 Fitting Unit Audiometer |