Devices (same UDI-DI)
1
Certificates
1
Countries
6
Notified Bodies
1
Basic Information
- Primary DI
- 08800056900000
- Basic UDI-DI Code
- B-08800056900000
- Reference
- F-LL 19G38(2)
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- Ovistech Co., Ltd.
Additional Description
Sterile absorbable polydioxanone(PDO) suture with needle consists of needle, needle cap, hub, sponge and polydioxanone (PDO) suture and is sterilizes by EO gas, the safety and effectiveness of polydioxanone(PDO) is not new in the market and This material has been distributed and used for more than 20 years in orthopedics, surgery, plastic surgery and ophthalmology.
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-108/2020 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
Available In Countries
🇩🇪 Germany
🇮🇹 Italy
🇱🇻 Latvia
🇵🇱 Poland
🇸🇪 Sweden
🇹🇷 Türkiye
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