Tyvek® 1059B Please provide an Executive Summary describing the assessment of the introduction of the Transition Tyvek Material for the products approved under the noted certificate 3. (Note: please clearly highlight any packaging process changes (Internal “Final” seal or supplier seals) required, and relevant mitigating activities) 2: Please provide a description of the Packaging Solution(s) utilised for the products certified under the relevant Annex II.4 certificate (252.XXX / 253.XXX) Example information outlined below: Sterile Barrier Packaging Process Device Model Number Sterile Barrier P/N (e.g Tyvek pealable Equipment (eg CVG-123) (e.g. xxxx-x) Pouch) (e.g. Sealer 1, 2, 3)
Tyvek® 1059B 3. Please provide an Executive Summary describing the assessment of the introduction of the Transition Tyvek Material for the products approved under the noted certificate (Note: please clearly highlight any packaging process changes (Internal “Final” seal or supplier seals) required, and relevant mitigating activities) 2: Please provide a description of the Packaging Solution(s) utilised for the products certified under the relevant Annex II.4 certificate (252.XXX / 253.XXX) Example information outlined below: Device Model Number (eg CVG-123) Sterile Barrier P/N (e.g. xxxx-x) Sterile Barrier (e.g Tyvek pealable Pouch) Packaging Process Equipment (e.g. Sealer 1, 2, 3)
GRF-25-49a.docx