Technical documentation section 1. Device description and specifications:

1.4 Basic UDI-DI document

The "Basic UDI-DI" document provides essential details for Unique Device Identification (UDI) compliance, particularly focusing on regulatory and traceability requirements. The document includes:

1. Document identification

• Title: "Basic UDI-DI"
• Document ID: Unique interlal identifier for tracking (as per your Document management procedure)
• Version number and effective date

2. Approval and revision history

• Details on the document's creation, review, and approval process
• Version history, including the date of issue and any modifications

3. Product information

• Identification of the product covered by the Basic UDI-DI (e.g., digital imaging software, medical mask, scalpel etc.)
• Description of internal product identifiers (if applicable)

4. Basic UDI-DI structure

• Components of the Basic UDI-DI, including:
• GS1 Company Prefix
• Internal product number
• Check character

5. Confidentiality and circulation restrictions

• Statement regarding the document's restricted use within the company
• Prohibition on sharing without written permission