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 |
05711781002675 - Measure/Unity 4 | 2024-05-06 |
05711781000022 - Primus By Auditdata | 2020-03-05 |
05711781001722 - OTOPro By Auditdata | 2020-03-05 |
05711781001739 - Primus By Auditdata | 2020-03-05 |
57117810001054 - Primus By Auditdata | 2019-07-08 |
05711781001050 - Primus By Auditdata | 2018-03-29 |
05711781001098 - Primus By Auditdata | 2018-03-29 |
05711781001227 - Entomed By Auditdata | 2018-03-29 |