Eu Mdd
Eu Md Class 2a
On The Market
๐ฐ๐ท South Korea
Biotex
Devices (same UDI-DI)
1
Certificates
1
Countries
1
Notified Bodies
1
Basic Information
- Primary DI
- 08800039003261
- Basic UDI-DI Code
- B-08800039003261
- Reference
- BT301655
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Purgo Biologics Inc.
Additional Description
Biotex is comprised of a single-arm, non-absorbable monofilament suture with a stainless-steel surgical needle connected to the suture. The suture is uncoated, undyed and single use only, composed of 100% high-density PTFE. Biotex is provided sterile by ethylene oxide and sterility is ensured by Tyvek pouch. Sterility of Biotex is valid 5 years after sterilization.
CND Nomenclature Codes
| Code | Description |
|---|---|
| H010201010501 | POLYTETRAFLUOROETHYLENE (PTFE) MONOFILAMENT WITH NEEDLE |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 1434-MDD-202/2021 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
Available In Countries
๐ฎ๐น Italy
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