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Basic Information
- Primary DI
- 08800077300001
- Basic UDI-DI Code
- B-08800077300001
- Reference
- DLMR
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- DEXLEVO INC.
Additional Description
GOURI is a premium collagen simulator, a fully solubilized liquid form of Polycaprolactone (PCL). PCL is degraded by hydrolysis of its ester linkages in physiological conditions (such as in the human body) and has therefore received a great deal of attention for use as an implantable biomaterial. In particular, it is especially interesting for the preparation of long-term implantable devices, owing to its degradation which is even slower than that of polylactide. Polycaprolactone (PCL) has been widely used in long term implants and controlled drug release applications.
CND Nomenclature Codes
| Code | Description |
|---|---|
| P900402 | RESORBABLE FILLING AND RECONSTRUCTION DEVICES |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | CE-MDD-0115/03/2021/01 | Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 3) and regulation (EU MDD).