Medtronic 1603200500 Instructions for Use

VeriFYI™ Data Carrier Tags M708348B437E Rev. B

2016-06-07

DESCRIPTION

The VeriFYI™ data carrier tags are intended to provide product traceability of the devices to which they are attached. These
tags provide an additional means to track specific devices to specific patients. Each tag is laser-marked with the part number,
UPN/GTIN, lot number, and, if applicable, size of the device to which the tag is attached. In addition, a 2D data matrix image,
encoded with the same information, is laser-marked on the tags. The tags are fabricated from Radel plastic with a barium
sulfate filler.

WARNING

Do not implant the VeriFYI™ data carrier tags. The tag must be removed prior to implantation of the device to which it
is attached.

Each tag is marked “DO NOT IMPLANT.” Tags are removed by breaking them in the center between the laser-marked
information.

Once removed, the tag should be saved so that the 2D matrix image can be scanned with a 2D matrix scanner. The scanned
information from the tag should be documented in the patient’s medical record for purposes of device traceability. In the event
that the 2D matrix is unable to be scanned, the device’s part and lot numbers can be manually captured as they are laser­marked on the tag and the device. Once the part and lot numbers are recorded, the tag may be discarded.

Refer to the tagged device’s package insert for specific information related to the tagged device and product complaint
reporting. Tags are to be sterilized by the parameters described in the tagged devices’ package insert(s). Tags should not be
removed prior to sterilization, but only prior to implantation of the tagged device.

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Australia
1800 668 670

EXPLANATION OF SYMBOLS

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Manufacturer

Consult instructions for use at this website.

Medtronic Sofamor Danek USA, Inc.

1800 Pyramid Place
Memphis, TN 38132
Telephone: [phone] (USA)
901 396 3133 (Outside USA)
Fax: [phone]

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6422 PJ Heerlen
The Netherlands
Tel: + 31 45 566 80 00