Name and Model: Device also marketed as (trade name), if known: If Applicable, UDI #: Software version (If Applicable): Lot / number(s): Serial number(s): Regulated Parties If Applicable, CAB / Entity legally representing the Notified Body #: Manufacturer: manufacturer: Country: Country: Full Address: Full Address: Contact: Contact: Telephone: Telephone: Email: Email: BACKGROUND INFORMATION AND REASON FOR THIS REPORT <background of query / notification of lead CA> Is the Investigation of the report Complete : Yes No Attachments : Yes No (… include info re manufacturer/assembly location) QUESTIONS AND RESPONSES (If Applicable)
Name and Model: Device also marketed as (trade name), if known: If Applicable, UDI #: Software version (If Applicable): Serial number(s): Lot / number(s): Regulated Parties Manufacturer: Entity legally representing the manufacturer: If Applicable, CAB / Notified Body #: Country: Country: Full Address: Full Address: Contact: Contact: Telephone: Telephone: Email: Email: BACKGROUND INFORMATION AND REASON FOR THIS REPORT <background of query / notification of lead CA> Is the Investigation of the report Complete : Yes No Attachments : Yes No (… include info re manufacturer/assembly location) QUESTIONS AND RESPONSES (If Applicable)
imdrf-tech-150326-pms-ncar-150410.docx