General Information

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Request Name

Owner *

Wesley Rugg

Type *

Labeling Change

DescriptionUpdate the printed carton label and IFU for Part 4821 to add the new UK Responsible Person details, refresh the symbols panel to EN ISO 15223-1:2021, and correct the storage temperature range to 2-30 °C. No change to device design, materials, sterilisation, or intended use. Affected markets are those where the current label revision (Rev C) is registered; translations of the revised label content are required for all local-language markets.

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Project Request Timeline

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Created Date

2026-08-13

Expected Completion Date

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