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Basic Information
- Primary DI
- 08800056900017
- Basic UDI-DI Code
- B-08800056900017
- Reference
- L-LL19G38(2)
- Device Types
-
Single use
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- Ovistech Co., Ltd.
Additional Description
Polydioxanone is used for biomedical applications, particularly in the preparation of surgical sutures. Other biomedical applications include orthopedics, plastic surgery, drug delivery, cardiovascular applications, and tissue engineering. It is degraded by hydrolysis, and the end products are mainly excreted in urine, the remainder being eliminated by digestive or exhaled as CO2. The biomaterial is completely reabsorbed in 6 months and can be seen only a minimal foreign body reaction tissue in the vicinity of the implant. Materials made of PDO can be sterilized with ethylene oxide
CND Nomenclature Codes
| Code | Description |
|---|---|
| H010101010104 | MOUNTED POLYDIOXANONE MONOFILAMENT WITH NEEDLE FOR TISSUE TRACTION (‘BARBED’) |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II Section 4 | 1434-MDD-109/2020 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
Available In Countries
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