| Primary Device ID | E23911311 |
| NIH Device Record Key | 4e1e294c-a7f7-4b6f-b814-23aae9c5633f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Silicone tubing |
| Version Model Number | 1131 |
| Catalog Number | 1131 |
| 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 |
| 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 | E23911311 [Primary] |
| ESD | Hearing Aid, Air-Conduction, Prescription |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-01-21 |
| Device Publish Date | 2025-01-13 |
| E23911411 | No. |
| E239202101 | No. |
| E239114101 | No. |
| E239113101 | No. |
| E23920211 | No. |
| E23911311 | No. |