Basic Information
- Primary DI
- 18904224918822
- Basic UDI-DI Code
- B-18904224918822
- Reference
- OBT8F
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- Meril Life Sciences Pvt. Ltd.
Additional Description
The Obtura™ Vascular Closure Device (VCD) is composed of a bio-absorbable implantand delivery component. Bio-absorbable implant contains a bio-absorbable polymer anchor, a bioabsorbable Type I bovine collagen sponge and a bio-absorbable suture that connects the anchor and collagen by self tightening knot. The delivery components comprise of the bypass tube that facilitate easy delivery system insertion through standard introducer sheath, the dual tube act as device shaft. The hub colour and marking the French size compatibility of the device .The hub and slider are connected with the inner and outer tube respectively and helps in device deployment by pulling the hub back till the indicative marker appears.
CND Nomenclature Codes
| Code | Description |
|---|---|
| C90010302 | COLLAGEN-BASED HAEMOSTASIS SYSTEMS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II Section 4 | 1434-MDD-250/2020 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
| MDD Annex II (excluding section 4) | 1434-MDD-251/2020 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 3) and regulation (EU MDD).