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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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In need of assistance?
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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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