Medical Device Labeling

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Medical Device Labeling

A UDI – which is a unique numeric or alphanumeric code – consists of two parts, the Device Identifier (DI) and the Production Identifier (PI). The Device Identifier (DI) is a mandatory, fixed portion that identifies the labeler and the specific version or model of a device. An example of this type of identifier is a GTIN. The Production Identifier (PI) is a conditional, variable portion of the UDI that identifies one or more of the following when included on medical device labeling:

  • Lot or batch number
  • Serial number
  • Expiration date (YYYY-MM-DD format required)
  • Manufacture date (YYYY-MM-DD format required)
  • Distinct identification code required by 21CFR1271.290 for any human cell, tissue, or cellular- and tissue-based product (HCT/P) regulated as a device.

Class I Devices only require the Device Identifier (DI).

Class II and III Devices require both the Device Identifier (DI) and Production Identifier (PI).

The UDI must be presented in two forms:

  • Easily-readable plain text
  • Automatic Identification and Data Capture (AIDC) technology

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Medical Device Labeling Material Considerations

Imprint Enterprises offers Zebra UDI label solutions for nearly any medical device labeling application.

  • Largest Offering of Pre-Tested Materials
  • Labels, Tags, Receipt Paper, Wristbands and Ribbons
  • Over 500 ZipShip items = Convenience
  • Over 80 pre-tested Materials in our Selector Guide
  • Access to many more materials through Supplies R&D
  • Including innovative products:
    • IQ Color
    • Z-Slip
    • Z-Band UltraSoft Wristbands

Quality is assured.

  • Imprint never substitutes materials, which ensures consistent print quality without the need to adjust darkness settings.
  • Zebra is ISO 9001-2008 certified, which means there are standard and consistent processes in place to ensure high-quality finished products.
  • Zebra has a computerized vision inspection system to ensure registration of pre-printed color, logos and text.

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UDI Labeling

Imprint Enterprises offers UDI medical device labeling solutions from Zebra Technologies. Zebra Z-Select 4000T labels are ideal for UDI carton labeling. These UDI labels can be used with applicators.

Key Features

  • Paper medical device labeling with high-tack permanent acrylic adhesive
  • Temperature exposure up to 200 degrees Fahrenheit.

Sterilization Resistance

  • Gamma radiation
  • Ethylene oxide

Chemical Resistance

  • Minimal resistance to moisture
  • Minimal resistance to chemicals

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Speak with one of our product experts.

Contact an Imprint team member today to get answers to all of your questions.

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