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Basic Information
- Primary DI
- 08809822314522
- Basic UDI-DI Code
- B-08809822314522
- Reference
- LFA23090150E
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- 21 Century Medical Co., Ltd.
Additional Description
Sterile single use polydioxanone(PDO) Suture with needle consists of needle, needle cap, hub, sponge and polydioxanone(PDO) suture and is sterilized by EO gas. The safety and effectiveness of polydioxanone(PDO) is acceptable because Polydioxanone(PDO) to be used to this device is absorb suture that has already used to sew the wound at normal hospital since 2001 and needle also has been used in hospital. Raw materials to use to this device have been used to many medical device as syringe and disposable medical devices.
CND Nomenclature Codes
| Code | Description |
|---|---|
| H010101010104 | MOUNTED POLYDIOXANONE MONOFILAMENT WITH NEEDLE FOR TISSUE TRACTION (‘BARBED’) |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 2195-MED-1421201-D01 | Szutest Uygunluk Değerlendirme A.Ş. | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 3) and regulation (EU MDD).