PRO3DURE IS-1.1
- Primary DI
- EPRCA0010100
- Brand
- PRO3DURE IS-1.1
- Company
- pro3dure medical GmbH
- Model
- 8 double cartridges of 2 x 25 ml
- Device description
- IS-1.1 - 8 double cartridges of 2 x 25 ml
- Published
- 2022-08-17
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| ESD | Hearing Aid, Air Conduction |
| LDG | Kit, Earmold, Impression |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| ESD | Hearing Aid, Air-Conduction, Prescription | Ear, Nose, Throat | 1 |
| LDG | Kit, Earmold, Impression | Ear, Nose, Throat | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| EPRCA0010100 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Earmould impression material | A rubber-like material used to replicate the shape of an individual's ear canal for the manufacture of custom-made hearing aids and earmoulds. The device may be supplied as a two-component silicone (base and catalyst) which produces the usable product. This is a single-use device. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Handling Environment Temperature | 18 Degrees Celsius | 28 Degrees Celsius | |
| Special Storage Condition, Specify | 0 | 0 | Keep away from sunlight |
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
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| EPRC66100849 | dima Print Denture Base 2 | 1kg - Original Pink | 66100849 | 2025-07-31 |
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| EPRC0220001A2 | ACRY PRINT RU-001 Temporary | 1000g ; A2 | 0220001A2 | 2025-03-31 |
| EPRC0220001A3 | ACRY PRINT RU-001 Temporary | 1000g ; A3 | 0220001A3 | 2025-03-31 |
| EPRC0220003 | ACRY PRINT RU-003 Try-In | 1000g ; A2 | 0220003 | 2025-03-31 |
| EPRC0220004 | ACRY PRINT RU-004 Denture HI | 1000g ; Orange-Pink | 0220004 | 2025-03-31 |
| EPRC0220005 | ACRY PRINT RU-005 Guide | 1000g ; Clear-Transparent | 0220005 | 2025-03-31 |
| EPRC768345 | UCAN Print Base | 1000g ; color 33 | 768345 | 2025-03-31 |
| EPRC768485 | UCAN Print Try-In | 1000g ; A2 | 768485 | 2025-03-31 |
| EPRC768486 | UCAN Print Splint | 1000g ; Transparent | 768486 | 2025-03-31 |
| EPRC768507 | UCAN Print Tray | 1000g ; Light-Pink | 768507 | 2025-03-31 |
| EPRCD1000808 | printodent GR-10 guide I MSI | 1000g ; ocean-blue | D1000808 | 2024-08-20 |
| EPRC6550 | IMPRIMO LC Splint comfort | clear-transparent, 1000g | 6550 | 2024-05-06 |
| EPRC6575 | IMPRIMO LC Splint comfort MSI | ocean-blue, 1000g | 6575 | 2024-05-06 |
| EPRCA0010200 | otosil IS-2 | 8 double cartridges of 2 x 25 ml | A0010200 | 2023-10-18 |
| EPRCA0011000 | otosil PS-1 | 2 x 300g ; Orange - White | A0011000 | 2023-10-18 |
| EPRCA0034150 | otosil SL-1 | 250 g - Clear Transparent | A0034150 | 2023-10-18 |
| 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