Indications 
Single-use scalpel designed for surgical procedures requiring the use of a scalpel

Used materials 
P

Labeling 
on each unit are written the reference, the lot/serial number, the sterilization method and the expiry date if applicable

medical device 

• MD class : IIa
• MD notified body : 2797
• EU directive/regulation : 2017/745
• annexe : IX

sterile 

• sterile : yes
• sterilization method : gamma ray

conformity 

• Instruments for surgery - Scalpels with detachable blades - Fitting dimensions
• Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
• Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements