Skip Navigation

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.
Learn more

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.
Learn more

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. 
Learn more

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 AND STERILIZATION INDICATORS

Sterile labels

Irradiated to eliminate microbial contamination

Autoclave indicator labels

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

ETO indicator labels

Color change under pressure, exposure, temperature and duration consistent with sterilization 

Gamma indicator labels

Color change under irradiation dose process consistent with sterilization 

Cleanroom Products

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. 

September 25, 2025

CleanMark Labels: 40 years solving the impossible

When Lon Martin founded CleanMark Labels in 1978, he wasn’t chasing easy sales — he was chasing problems no one else could solve. And customers noticed. What began as a …
September 18, 2025

Optimizing lab labels for high-performance aseptic operations: hybrid sterile + cleanroom-compatible labels

Key takeaways High-tech fields like medical device manufacturing and pharma depend on aseptic areas and cleanrooms that are built for precision, but many still rely on lab labels that fall …
June 24, 2025

5 steps to tame the change management process

Great news — you have a sure-fire proposal for how to make your manufacturing operations more efficient and successful. But, you don’t have the faintest idea how to convince the …

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?

Gloss

Provides a shiny, gloss finish — not recommended for QR and bar codes

Matte

Matte finish — great for detailed images and text that require high print clarity

Laminated

Versatile technique to provide added protection to printing, change label stiffness, or modify label gloss

EtO

Contains EtO‑sensitive ink that visibly and permanently shifts color once proper ethylene oxide gas exposure conditions have been met

Gamma

An indicator chemical compound irreversibly changes color when exposed to a validated dose of gamma radiation, offering fast visual confirmation of sterilization

Autoclave

Heat‑sensitive ink permanently changes color once the required steam temperature and dwell time have been achieved in an autoclave cycle

QR code

Only select if CleanMark will print the QR code during production

Bar code

Only select if CleanMark will print the bar code during production

Serial number

Only select if CleanMark will print the serial number during production

100% pre-printed

CleanMark prints the entire label, including any variable data like bar codes or serial numbers

Partially pre-printed

CleanMark prints static info but leaves space for handwritten or on-site printing of variable or time-dependent data

Blank

Label is completely blank upon delivery

Direct thermal

Uses heat-sensitive film and a heated print head to create images without ink or ribbons

Thermal transfer

Transfers ink from a ribbon onto the label using heat for long-lasting, durable prints

Ink jet

Sprays tiny droplets of ink directly onto the label surface for full-color, high-resolution prints

Laser

Uses a laser beam and toner to produce crisp, smudge-resistant labels with sharp detail

Handwritten

Labels are manually marked using a pen or marker, offering maximum flexibility but limited consistency

Yes

Not appropriate for machine application

Paper

Affordable, efficient option that accepts ink well. Great for cardboard label application. Not appropriate for cleanrooms.

Polyamide (nylon)

Good option for garments and screen printing

Polyimide

Cleanroom compatible option perfect for electronics and other high heat applications

Polyester

Versatile facestock perfect for high-heat and chemical exposure contexts.

Polycarbonate

Stiffer facestock that can be printed or extruded in a variety of colors. Great for nameplates.

BOPP (biaxially oriented polypropylene)

Versatile, affordable option with high flexibility and direct thermal options.

Polyethelene

Absorbs color ink well and has high flexibility for adhering to tightly curved surfaces like vials and syringes

Permanent

Remains firmly adhered throughout the intended lifecycle, then can be removed after use residue free

Removable

Designed for easy, residue-free removal after a short to medium lifecycle

Repositionable

Designed to be repositioned during lifecycle — perfect for tracking labels that must move from a component or product to a documentation sheet

Synthetic (clear)

Best for gap sensing printers

Synthetic (colors)

Best for printers that require opaque liners or where clear liner would be a safety issue, such as warehouses, labs, and shipping facilities

Paper

Available in a variety of thicknesses — not suitable for cleanrooms

Paper

Not suitable for cleanrooms

Plastic

Color options available

Glass

Glass

Metal

Metal

Plastic

Plastic

Cardboard

Cardboard

Flat

Includes flat surfaces of all sizes

Curved

Includes vials, beakers, syringes, and any other non-flat surface

Chemical resistant

Remain adhered and legible through exposure to cleaning and other chemicals

Heat resistant

Resist yellowing and discoloration, remaining adhered and legible through heat-intensive processes (100C - 250C)

Freezer

Designed to remain legible and adhered at both freezer (-80C - 0C) and ambient temperatures

Cryogenic

Firm, cold-specific adhesive ensures reliable performance at ultra-low temps (-196C to -86C) and around tight curves, like vials and syringes.

Dry ice

Use flexible materials and adhesive that remain secure and legible when moved in and out of dry ice conditions (-86C to -70C)

Refrigerator

Designed to remain legible and adhered at both refrigerator (0C - 20C) and ambient temperatures with a high degree of moisture resistance

Autoclave durable

Ultra-durable labels that withstands the moisture, temperature (121C or higher), and pressure of the autclave process and can be designed for residue-free removal

Abrasion resistant

Withstand the rigors of shipping and other high-abrasion environments without smearing, degrading, or peeling

UV resistant

Reliable adhesion and legibility through prolonged outdoor exposure

Moisture resistant

Moisture-resistant adhesives and synthetic label materials ensure reliable adhesion and legibility in humid or wet conditions.

Cleanroom labels

CleanMark can produce clean labels up to ISO 5 cleanroom standards. We process labels in our own cleanroom and are ISO 9001:2015 certified. Cleanroom labels are double bagged.

Sterile labels

CleanMark's sterile labels are gamma irradiated after packing. Optional sterility validation testing is available.

Hand applied

Designed for fast, easy hand application

Machine applied

Labels can be customized for your specific label applicator machine

Roll

Labels are wound on a roll

Fanfold

Flat sheets of labels

Labels

3 in.

1.5 in.

1 in.

3/4 in.

Square / rectangle

Circle

Irregular

Width (in.)

Height (in.)

Diameter (in.)

1

2

3

4

5

6