UDI / GTIN check digit
GS1 modulo-10 check digit used in many UDI-DI encodings (GTIN-8/12/13/14). Does not validate issuing agency, packaging level, or FDA GUDID listing.
How to use the UDI / GTIN check digit validator
Paste an 8-, 12-, 13- or 14-digit GTIN (spaces and AI parentheses are ignored) and confirm the check digit. Parse expiry, lot and serial from a human-readable AI string with the GS1 UDI AI parser, sketch aging claims with the shelf-life Q10 estimator, or shortlist modalities with the sterilization modality picker.
Standing up UDI-DI issuance or GUDID submissions?
A valid check digit is necessary but not sufficient. Book a Consultation with our regulatory team to align issuing-agency rules, packaging levels and FDA UDI labeling with your device family.
Book a ConsultationFAQ
- What check digit does GS1 use for GTIN / UDI-DI?
- GS1 GTINs (GTIN-8, GTIN-12, GTIN-13, GTIN-14) use a modulo-10 check digit computed from the preceding digits with alternating weights of 3 and 1 from the right. Many FDA Unique Device Identifier device identifiers (UDI-DI) that use GS1 encode a GTIN, so the same check digit applies.
- What do FDA’s UDI rules require at a high level?
- FDA’s unique device identification system is set out in 21 CFR Part 830, with related labeling provisions such as 21 CFR 801.20. Devices generally must bear a UDI on the label and packages unless an exception or alternative applies, and device identifiers are submitted to GUDID. This tool only checks the GS1 arithmetic — not issuing-agency assignment, packaging hierarchy or GUDID content.
- Which lengths does this validator accept?
- Eight, twelve, thirteen or fourteen digits (GTIN-8 / GTIN-12 / GTIN-13 / GTIN-14). Spaces, parentheses and Application Identifier wrappers are stripped before the check. Other issuing agencies or non-GTIN formats are out of scope.
- Does a valid check digit mean the UDI is FDA-listed?
- No. A matching check digit only means the digit string is internally consistent under GS1 rules. Issuing-agency registration, correct packaging level, production identifiers and GUDID submission are separate obligations.
- How do I compute a missing check digit?
- Enter the body digits plus a placeholder last digit (or an incorrect one). When the check fails, the result shows the expected check digit and a suggested full string. Confirm against your issuing-agency allocator before printing labels.
- Should I also parse Application Identifiers?
- Yes when the barcode carries AI elements such as (01) GTIN, (17) expiry, (10) lot and (21) serial. Use the GS1 UDI AI parser for the human-readable AI string; use this page for the GTIN check digit itself.
Educational only. Not medical advice, not a regulatory determination, and not a substitute for qualified RA/QA, legal, clinical, or statistical counsel. UDI / GTIN check digit does not submit to FDA, Notified Bodies, or IRBs.
Related UDI & packaging tools
Standing up UDI-DI issuance or GUDID submissions?
A valid check digit is necessary but not sufficient. Book a Consultation with our regulatory team to align issuing-agency rules, packaging levels and FDA UDI labeling with your device family.
Book a Consultation