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Build customer trust with CleanMark sterile indicating medical device labels

Your customers need to know your product is sterile. Our gamma irradiation indicating medical device labels provide that assurance and can be customized to highlight brand and product information — all on one label.

Upgrade to custom labels

  1. Give us some initial information
  2. Talk to a label expert
  3. Review and test your custom label
  4. Production and shipping
A machine with medical device labels on the front

A standard label can’t do what you need it to

When you’re designing and manufacturing medical devices that are pushing the boundaries of healthcare, you’re not going to find an off-the-shelf label that meets your product requirements and provides customers with assurance of sterility. You need a CleanMark custom label.

  • Designed by engineers with medical device expertise
  • Optimized for multi-factor use
  • Backed by a team committed to your continuing innovation

Learn more about how we customize medical device labels

A large medical devicie

Labels as innovative as your medical devices

CleanMark has been pioneering labeling technology for 40 years. We thrive on the challenge of creating new labeling solutions to meet the evolving needs of our high-tech customers.

Sterilization indication

Add autoclave, gamma irradiation, or EtO sterilization indicator ink to  your custom label to demonstrate that sterilization processes have been successfully completed.
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Durability

Medical device labels have to remain legible in extreme conditions, be they inside or outside the human body. CleanMark labels withstand moisture, head, cold, chemicals, and anything else you throw at them.
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Biocompatibility

We process our sterile labels in an ISO 5 cleanroom, sterilize them using gamma radiation or EtO, and package them to ensure they arrive at your facility free of contamination. 
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Solutions for all your medical label needs

From biocompatible tracking to sterilization indicators, we have every label you need to develop and produce your medical device.

Sterile labels

Irradiated to eliminate microbial contamination

Autoclave indicator labels

Easy-to-read results based on steam, temperature, and time

ETO indicator labels

Indicate successful sterilization by ethylene oxide gas

Gamma indicator labels

Change color to indicate sterilization by gamma radiation

Cleanroom Labels

No particulate contamination or outgassing

Cleanroom Tape

Useful for sealing packaging and protective garments and marking floors

Cleanroom Tags

Flexible, contamination-free identification

Chemical resistant labels

Resistant to degradation caused by harsh chemicals

Heat resistant labels

Maintain integrity and legibility at high  temperatures

Freezer labels

Designed for temperatures between 0°C and -40°C

Cryogenic labels

Ideal for liquid nitrogen environments of -196°C

Refrigerator labels

Cold chain labels designed for use between 2°C to 8°C

Dry ice labels

Optimized for ultra-low temp lab freezers between -40 °C and -80 °C

Waterproof labels

Maintain integrity and legibility in high-moisture environments

Direct thermal labels

Optimized for use with direct thermal printers like Zebra and DYMO 

Thermal transfer labels

Perfect for Zebra, DYMO and other thermal transfer printers 

Laser labels

Ideal for detailed text and graphics printed on major laser printers

Inkjet labels

Optimized for vibrant colors printed on major inkjet printers

Get real-world insight into the benefits of custom-engineered medical device labels

CleanMark builds lasting partnerships with medical device manufacturers to address their specific labeling needs. Explore our case studies to see how CleanMark’s tailored solutions overcome real-world operational challenges.

Case Study

Invisible Sentinel | Save time and resources with multi-purpose autoclave labels

Learn how Invisible Sentinel streamlined their processes and reduced resource use with multi-purpose autoclave labels from CleanMark.
Case Study

Ionis Pharmaceuticals | Optimizing equipment management with QR code labels

Learn how Ionis Pharmaceuticals optimized equipment management with CleanMark’s custom-engineered, durable QR code labels.
Case Study

Access Biologicals | Integrated gamma labels with cryogenic adhesive

Learn how CleanMark designed integrated gamma labels with cryogenic adhesive to meet the unique operational needs of Access Biologicals.

Looking for more detailed information about medical device labels?

Explore case studies, articles, guides and more in our extensive library of labeling resources. 

November 7, 2024

What is the ISO standard for implantable medical device labeling requirements?

What’s the ISO standard for implantable medical device labeling requirements? Read on to learn which requirements your label needs to satisfy.
October 31, 2024

Autoclave tape guarantees safety in high-sensitivity industries like pharma and biotech

In sensitive industries like pharma and biotech, autoclave tape is the difference between patient safety and costly recalls.
Thermal printing labels
October 30, 2024

5 ways thermal printing labels save you time and resources

Thermal printing labels give you the efficiency of preprinting and the flexibility of on-site customization in a durable label.

Have more questions? We have answers!

Read on for answers to our customers’ most common questions.

What types of custom medical device labels can you create?
How do you ensure your custom medical device labels comply with ISO and FDA standards?
What materials and adhesives are available?
Can you design labels for small or uniquely shaped medical devices?
Do you provide tamper-evident and anti-counterfeit options?
How do you ensure label adhesion on specific medical device materials?
Can you design labels to withstand autoclaving or other sterilization processes?
What customization options are available for printing and design?
How can your labels improve traceability in medical device manufacturing?
Do you offer consultation on label design for regulatory compliance?