Component function and finished assembly: Order boundary: component, subassembly or finished device: Drawing revision, material requirement and sample quantity: Planned prototype evaluation and permitted sample use: Intended direct/indirect body contact, surfaces and duration, or unresolved items: Destination and responsible device/quality reviewers: Required machining, finish, cleaning, packaging and supplied state: Sterilization relevance and process responsibility, if applicable: Material identity/lot, process and individual inspection records needed: Specialist evaluation planned and missing information: Proposed deviations, material/process/site changes and notification: Acceptance authority, disposition and remaining production work: Please separate sample manufacture, documentation, inspection and additional evaluation work.