otosil ES-1.1
- Primary DI
- EPRCA0031603
- Brand
- otosil ES-1.1
- Company
- pro3dure medical GmbH
- Model
- Shore 40 / 8 double cartridges of 2 x 24 ml - redd
- Catalog number
- A0031603
- Device description
- ES-1.1 / 40 Shore reddish-transparent 8 double cartridges with 48 ml each
- Published
- 2022-09-12
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| ESD | Hearing Aid, Air Conduction |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| ESD | Hearing Aid, Air-Conduction, Prescription | Ear, Nose, Throat | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| EPRCA0031603 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Earmould, custom-made | A custom-made device designed to fit in an individual ear, made from an impression of that ear, and through which the acoustic output from a hearing aid is conveyed to the eardrum, or in which transducer components of a hearing aid are aligned. It is made of synthetic polymer materials. This is a reusable device. |
Contacts
| Phone | Email |
|---|
| +4923749200500 | info@pro3dure.com |
Regulatory Flags
- DUNS number
- 312947842
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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| EPRCA0034151 | otosil SL-1 | 100 g - Clear Transparent | A0034151 | 2023-10-18 |
| EPRCA0034160 | otosil SL-1 I MSI | 250 g - Clear Transparent | A0034160 | 2023-10-18 |
| EPRCA0034300 | otosil protect 50 I MSI | neon-yellow | A0034300 | 2023-10-18 |
Other Devices Sharing Product Codes
pro3dure.com