| Primary Device ID | 09120041050077 |
| NIH Device Record Key | e81cc296-36b4-4004-90ca-2d0df1c58430 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | contact star evo1 |
| Version Model Number | CONTACT-STAR-EVO1/L/BR |
| Catalog Number | 77733334 |
| Company DUNS | 300632705 |
| Company Name | BHM-Tech Produktionsgesellschaft m.b.H. |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
| Phone | +43335920078 |
| nice_2_hear_u@bhm-tech.at |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09120041050077 [Primary] |
| LXB | Hearing Aid, Bone Conduction |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-04-06 |
| Device Publish Date | 2016-09-20 |
| 09120041050107 | contact star evo1, right, black, bone-conduction hearing system |
| 09120041050091 | contact star evo1, left, black, bone-conduction hearing system |
| 09120041050084 | contact star evo1, right, brown, bone-conduction hearing system |
| 09120041050077 | contact star evo1, left, brown, bone-conduction hearing system |