Medical Device Traceability, UDI and Device History Records

Independent · source-linked · manufacturing-first

Traceability is the ability to connect the physical device to the records that explain what it is, which revision built it, what material and processes it received, who accepted it and how it was labeled.

Manufacturing identity

A controlled route can connect raw-material heat or lot, work order, machine and program revision, in-process results, outside processing, cleaning, inspection, nonconformance decisions and final release. The exact record set depends on the product and quality system.

UDI is a market identity layer

FDA established the UDI system to identify medical devices through distribution and use. A UDI generally includes a device identifier and, where applicable, production identifiers. UDI does not replace internal manufacturing traceability; the two systems should connect appropriately.

Use GUDID correctly

AccessGUDID exposes identification information submitted to FDA and is available without an account. It can help verify device identifiers, company names and selected public attributes, but it is not a complete manufacturing traveler or proof of current inventory.

Control labels and data

Label content, label revision, device configuration and database records need synchronized change control. Manual retyping and detached spreadsheets create opportunities for mismatches that a barcode cannot solve on its own.

Continue the medical manufacturing map

Independent educational reference: Machine Blue Book is not affiliated with Arthrex, FDA, ISO or any manufacturer named on this page. Names are used descriptively and linked to primary sources. This material is not medical, legal, regulatory or clinical advice and does not recommend a device for patient care.