| Primary Device ID | 05711781003153 |
| NIH Device Record Key | de0e6614-8582-4d49-8915-c2849b3dc7fc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Auditdata A/S |
| Version Model Number | UNITY 4 |
| Catalog Number | 21031184 |
| Company DUNS | 157412271 |
| Company Name | Ws Audiology Usa, Inc. |
| 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 | false |
| 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 | 17325626600 |
| consumerrelations@sivantos.com | |
| Phone | 17325626600 |
| consumerrelations@sivantos.com | |
| Phone | 17325626600 |
| consumerrelations@sivantos.com | |
| Phone | 17325626600 |
| consumerrelations@sivantos.com | |
| Phone | 17325626600 |
| consumerrelations@sivantos.com | |
| Phone | 17325626600 |
| consumerrelations@sivantos.com | |
| Phone | 17325626600 |
| consumerrelations@sivantos.com | |
| Phone | 17325626600 |
| consumerrelations@sivantos.com | |
| Phone | 17325626600 |
| consumerrelations@sivantos.com | |
| Phone | 17325626600 |
| consumerrelations@sivantos.com | |
| Phone | 17325626600 |
| consumerrelations@sivantos.com | |
| Phone | 17325626600 |
| consumerrelations@sivantos.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05711781003153 [Primary] |
| EWO | Audiometer |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-26 |
| Device Publish Date | 2024-08-16 |
| 05711781003160 | UNITY 4 INSITU PACKAGE |
| 05711781003153 | UNITY 4 AUD + REM US PACKAGE |
| 05711781003122 | UNITY 4 AUD US PACKAGE |