Swann-Morton

Primary DI

05033955060527

Basic UDI-DI Code

50339550NONSTFINEHANDLE4K

Reference

6052 - SF2 Fine Surgical Handle

Device Types

Sterilization

Regulation

Eu Mdr

Classification

Eu Md Class 1

Status

On The Market

Manufacturer

Swann-Morton Ltd

“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.”

The Basic UDI-DI associated with this device has 8 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Other on-the-market devices with the same classification (Eu Md Class 1) and regulation (EU MDR).