| Primary Device ID | E239234501 |
| NIH Device Record Key | df3ab65c-fcb0-45b6-9b77-dd09a7fc33d3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pre-bent tubing |
| Version Model Number | 23450 |
| Catalog Number | 23450 |
| Company DUNS | 315808340 |
| Company Name | Dreve Otoplastik GmbH |
| 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 | 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 | false |
| OTC Over-The-Counter | false |
| Phone | +49230388070 |
| otoplastik@dreve.de | |
| Phone | +49230388070 |
| otoplastik@dreve.de | |
| Phone | +49230388070 |
| otoplastik@dreve.de | |
| Phone | +49230388070 |
| otoplastik@dreve.de | |
| Phone | +49230388070 |
| otoplastik@dreve.de | |
| Phone | +49230388070 |
| otoplastik@dreve.de | |
| Phone | +49230388070 |
| otoplastik@dreve.de | |
| Phone | +49230388070 |
| otoplastik@dreve.de | |
| Phone | +49230388070 |
| otoplastik@dreve.de | |
| Phone | +49230388070 |
| otoplastik@dreve.de | |
| Phone | +49230388070 |
| otoplastik@dreve.de | |
| Phone | +49230388070 |
| otoplastik@dreve.de | |
| Phone | +49230388070 |
| otoplastik@dreve.de | |
| Phone | +49230388070 |
| otoplastik@dreve.de |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | E239234501 [Primary] |
| ESD | Hearing aid, air conduction |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-26 |
| Device Publish Date | 2022-08-18 |
| E239045501 | No. |
| E239045101 | No. |
| E239235501 | No. |
| E239235101 | No. |
| E239234501 | No. |
| E2390411001 | No. |
| E239043101 | No. |
| E2390431001 | No. |
| E239041101 | No. |
| E239234101 | No. |
| E239042501 | No. |
| E23904171501 | No. |
| E23904171101 | No. |