Medtronic 2159008 Instructions for Use

FOR US AUDIENCES ONLY

M708348B497E Rev. C

Medtronic Transportation/
Sterilization Cassettes

2020-03-05

IMPORTANT INFORMATION FOR MEDTRONIC TRANSPORTATION/STERILIZATION
CASSETTES

DESCRIPTION

The Medtronic Transportation/Sterilization Cassettes include cases, trays, lids, caddies, modules, or brackets fabricated from a
variety of materials commonly used to enclose, protect, and organize Medtronic orthopedic or neurological non-sterile devices
which meet national or international specifications. The Medtronic Transportation/Sterilization Cassettes are not intended on
their own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization
wrap.

INTENDED USE

The Medtronic Transportation/Sterilization Cassettes are intended for use in healthcare facilities to organize, enclose, sterilize,
transport, and store medical devices and other instrumentation between surgical and other medical uses. The Medtronic
Transportation/Sterilization Cassettes are not intended on their own to maintain sterility; they are intended to be used in
conjunction with a legally marketed, validated, FDA-cleared sterilization wrap. The Medtronic Transportation Sterilization
Cassettes are intended for transport of non-sterile loads.

Sterilization validations for the worst case Medtronic Transportation/Sterilization Cassettes (22.75 x 11.26 x 5.5 inches) included
implants and common surgical instruments such as rasps, drivers, trials, handles, inserters, probes, drills, etc. The validated
total weight was 28.4lbs. The validated worst case loading configurations of the Medtronic Transportation/Sterilization Cassettes
included the following worst case lumen dimensions:

▪ 363 x 1.575mm
▪ 247.5 x 4.1mm

Device List:

▪ P1850078 General Triple Outer Case (22.74×11.26×5.04 inches)
▪ P1850079 Generic Outer Case (22.75×11.26×.470 inches)
▪ 7022101L Implant Lid (21.00×10.13×.075 inches)
▪ P1850010 Tray 1 (20.71×9.82×4.4 inches)
▪ P1850011 Tray 2 (18.81×9.50×2.8 inches)
▪ P1850012 Tray 3 (18.30×9.20×.840 inches)
▪ P1850013 Screw Caddy (9.4×5.3×1.49 inches)
▪ P1850014 Screw Caddy Lid (9.40×5.045×095 inches)
▪ P1850015 Connector Caddy (2.00×1.50×1.025 inches)
▪ P1850016 Connector Caddy Lid (2.0×1.245×.095 inches)

FOR US AUDIENCES: Please refer to 0380035 IFU for Sterilization instructions.
©2020 Medtronic Sofamor Danek USA, Inc. All rights reserved.

Medtronic Sofamor Danek USA, Inc.

1800 Pyramid Place
Memphis, TN 38132
Telephone: [phone] (USA)

901 396 3133 (Outside USA)

Fax: [phone]

EXPLANATION OF SYMBOLS

Batch code

Non-sterile

Manufacturer

Catalogue number

Consult instructions for use at this website.