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Symbols and Definitions
Use by date
Consult accompanying instructions
Manufacturer
Date of Manufacture
REF
Orderable/Catalogue part number
LOT
Lot number/Batch code
CE marked by BSI 0086 per the Medical Device
Directive 93/42/EEC
Indicates a medical device that can be broken or
damaged if not handled carefully.
Inflation Volume
Introducer Sheath Size
Supplied sterilized by ethylene oxide gas and for single use only.
non-pyrogenic only if the package is not opened or damaged.
Caution: United States Federal law restricts this device to sale by or on the order of a physician.
Indicates a medical device that should not be used if the package has been damaged or opened.
60˚C
Indicates the temperature limits to which the medical device can be safely exposed.
-20˚C
1204-001 Revision C.1
Caution, consult accompanying
instruction for safety information
Not made with natural rubber latex
Single Use, Do not reuse
DEHP free
Do not re-sterilize
Email Address
Phone Number
Keep Dry
Rated Burst Pressure
Authorized Representative in the
European Community
The package is sterile and
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