Basic Information
- Primary DI
- 05033955058104
- Basic UDI-DI Code
- 50339550NONSTPDHANDLEGU
- Reference
- 5810 - Non Sterile PD Handle
- Device Types
-
Sterilization
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 1
- Status
- On The Market
- Manufacturer
- Swann-Morton Ltd
Additional Description
“The handles are marked with CE 2797 only. As per Annex VI Part C (4.10) Devices that are reusable shall bear a UDI carrier on the device itself. The UDI carrier for reusable devices that require cleaning, disinfection, sterilisation or refurbishing between patient uses shall be permanent and readable after each process performed to make the device ready for the subsequent use throughout the intended lifetime of the device. The requirement of this Section shall not apply to devices in the following circumstances: (a) any type of direct marking would interfere with the safety or performance of the device; (b) the device cannot be directly marked because it is not technologically feasible.”
CND Nomenclature Codes
| Code | Description |
|---|---|
| L010103 | HANDLES FOR SCALPELS, REUSABLE |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 1) and regulation (EU MDR).