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Computype Unique Device Identification (UDI) Medical Device Labeling Assessment
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Catalog No. CMPUDIASSMT
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FDA 21CFR UDI
Catalog No. CMPUDIASSMT Supplier Computype Supplier No. CMPUDIASSMT

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FDA 21CFR UDI

Description

Our comprehensive assessment addresses FDA 21CFR UDI requirments by reviewing best practices to support accurate and efficient medical device identification.

The FDA established the Unique Device Identification system to identify medical devices sold in the United States from manufacturing through distribution to patient use. Computype can assess your new product requirements or existing way of work for workflow enhancements. There are several ways to uniquely identify a device, and Computype has experts that can advise on which options will work for your specific application so you are not only in compliance but following best practices.

  • Bar code printing, grading and scanning expertise that ensures performance and compliance.
  • On-demand labeling options
  • Preprinted label options
  • Sequence management
  • Durable materials that withstand freezing, thawing, and chemical exposure to ensure your device identification.
  • Cryogenic environments
  • Nase free environments
  • Extreme heat exposure
  • Sterilization ready materials
  • Environmental friendly sustainable label materials
  • Label printer support and recommendations and optimization with your workflow in mind.
  • Bar code label printing software and associated design programming
  • Color coding for clarification and workflow efficiency
  • Automatic labeling automationLabware Prep - outsource the labeling of components and tubes for ultimate convenience and accuracy
  • Direct mark ink-jet
  • Laser marking

Specifications

Product Type Workplace Safety Compliance Assessments
Federal Regulation FDA 21 CFR
Product Title
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