Medical Device Part Marking
IDENTIFICATION MARKING ON MEDICAL DEVICES
In order to meet industry standards, medical devices must be marked or engraved to provide a reliable and readable ID number for each part. GT SCHMIDT manufactures laser marking machines for medical device manufacturers to help meet their strict product identification, device serialization, and traceability guidelines.
GT SCHMIDTtakes up the various challenges and multifaceted requirements and develop reliable solutions for medical device marking. We understand the importance of not only ensuring the proper marking of all medical products but also the capability of improving medical device safety and regulations.
FDA UDI REGULATIONS
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 requirements help reduce medical errors and more quickly identify medical devices for documentation and in the case of recalls.
BENEFITS OF LASER MARKING MEDICAL COMPONENTS
- Permanent and Durable Markings: Laser marking creates highly durable markings that are resistant to wear, corrosion, and fading. This ensures that the UDI remains legible throughout the lifespan of the part, meeting strict industry requirements for traceability and accountability.
- High Precision and Accuracy: Laser technology provides exceptional precision and accuracy, capable of intricate UDI markings with precise dimensions and fine details. This is crucial for maintaining readability and ensuring accurate identification of parts.
- Non-contact and Non-destructive: Laser marking is a non-contact process that does not require direct contact with the surface of the part, minimizing the risk of damage or deformation. This is particularly important for medical components, where surface integrity must be preserved to deter the growth of bacteria.
MARKING APPLICATIONS FOR MEDICAL DEVICES
- Unique Device Identification (UDI) Marks
- Lot & Batch Numbers
- Serial Numbers & Expiration Dates
- Manufactured Date & Production Identifiers
- Device & Application Codes
- FDA & CFR Required Marks
- UDID Database Codes
- Permanent Identification
- Device Traceability
BENEFITS OF MARKING MEDICAL COMPONENTS
GT 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.
- Corrosion Resistant Marks
- Improves Patient Safety
- Simplifies Product Recalls
- Improves Productivity
Medical Component Materials
Metals and alloys:
- Titanium
- Stainless steel
- Cobalt-chromium
- Tungsten
- Tantalum
Polymers:
- Polycarbonate
- PVC
- PE
- PP
- PS
- PET
- PEEK
- Silicone
- Nylon
DO YOU NEED A PERMANENT MARKING SOLUTION FOR MEDICAL COMPONENTS?
Are you seeking efficient part-marking solutions for your medical components? Reach out to us now to discuss your needs and discover how our laser marking systems, rotary roll marking machines, and the rest of our products can help you satisfy FDA UDI requirements.
need a custom solution?
Our in-house design and engineering department has a full range of services and support to ensure that your marking application is successful.
Why GT SCHMIDT?
At GT SCHMIDT, we design, build, and implement marking solutions that help manufacturers leave a lasting mark on their products, their companies, and their industries.
Learn More About Us
made in usa since 1895
125 years of experience
installation & follow-up support
