Identification Marking on Medical Devices

identification marking on gas cylinders

SCHMIDT manufactures laser marking machines for medical device manufacturers to help meet their strict product identification, device serialization and traceability guidelines.

The FDA requires medical device manufacturers to have a unique device identifier also known as UDI. Beyond labeling their products, some medical devices like surgical equipment, implantables, life-supporting devices, and life-sustaining devices are required to bear a permanent direct product marking. These devices require both a unique device identifier and production identifiers (expiration dates, serial numbers, lot and batch numbers). These unique identifiers are required so the medical devices can be traced from the time they were manufactured, through their distribution, on to final use. These strict requirments help reduce medical errors and more quickly identify medical devices for documentation and in the case of recalls.

Video is demonstrating our GeoMARK Pro and GeoMARK Eco lasers.

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FEATURES & BENEFITS

Unique Device Identification (UDI) Marks

  • FDA & CFR Compliance Marks

  • Lot & Batch Numbers

  • Serial Numbers & Expiration Dates

  • Manufactured Date & Production Identifiers

  • Device & Application CodesĀ 

  • UDID Database Code Validation

Laser Marking Benefits

  • Permanent Identification

  • Device Traceability

  • Achieve Compliance Faster

  • Corrosion Resistant Marks

  • Improves Patient Safety

  • Simplifies Product Recalls

WHY LASER MARKING?

SCHMIDT manufactures lasers markers for laser annealing on non-ferrous high grade metals, and for high contrast marks on plastics without using any solvents or additives. The lasers produce a low local heat that changes the color of the surface layer. The resulting mark is permanent and the surface of the material remains intact eliminating grooves and the potential for bacteria to grow. Laser marks done with the annealing process are corrosion resistant and can withstand many sterilization processes such as, passivation, centrifuging, and autoclaving.

Types of Material

laser marking medical devices laser marking medical devices

Metals: Titanium, stainless steel, cobalt-chromium, tungsten, tantalum and other medical grade alloys

 

Polymers: Polycarbonate, PVC, PE, PP, PS, PET, PEEK, silicone, nylon and more

LASER MARKING MACHINES

SCHMIDT manufactures both class I certified laser enclosures and class IV open environment laser workstations.

Our class I enclosures adhere to federal protective housing guidelines, are guaranteed light tight and do not emit any laser beam or radiation. These laser systems can be equipped with rotary devices and special part fixtures for added support during the marking cycle. Our class IV open environment lasers are great for marking a variety of part shapes and sizes without limitation. They offer a sped up marking process and easy integration.

FEEL CONFIDENT IN YOUR PURCHASE

Send us a few samples of your parts and we will laser mark them here in our lab. We will show you how our laser marking machines can get you the specification marks required. Fill out the form to send us your samples. Or call us at 847-647-7117. For 125 years, SCHMIDT has been at the forefront of innovative marking technology. Our team is ready to help install and support your ideal marking system today.