User Manual

Manufacturer
Indicates the medical device manufacturer
ISO 15223-1:2016 Ref. 5.1.1
Authorized Representative
Indicates authorized representative in
the EU
ISO 15223-1:2016 Ref. 5.1.2
Date of Manufacture
Indicates date when device was
manufactured
ISO 15223-1:2016 Ref. 5.1.3
Use by Date
Indicates date after which the device is
not to be used
ISO 15223-1:2016 Ref. 5.1.4
Batch Code
Identiesthemanufacturer'slotorbatch
code
ISO 15223-1:2016 Ref. 5.1.5
Catalog Number
Indicatesthemanufacturer'spart
number
ISO 15223-1:2016 Ref. 5.1.6
Serial Number
Identiesthemanufacturer'sserial
number
ISO 15223-1:2016 Ref. 5.1.7
Sterile
Indicates that a device has been subject
to sterilization
ISO 15223-1:2016 Ref. 5.2.1
Do not use if package is damaged
Indicates device should not be used if
opened
ISO 15223-1:2016 Ref. 5.2.8
Non-Sterile
Indicates a device has not been subject
to sterilization
ISO 15223-1:2016 Ref. 5.2.7
Fragile, handle with care
Indicates device that needs careful
handling
ISO 15223-1:2016 Ref. 5.3.1
Keep away from sunlight
Indicates a device needs protection from
sunlight
ISO 15223-1:2016 Ref. 5.3.2
Temperature limit
Indicates upper and lower temperature
limits
ISO 15223-1:2016 Ref. 5.3.7
Keep dry
Indicates device should be protected
from moisture
ISO 15223-1:2016 Ref. 5.3.4
Do not reuse
Indicates a single use device
ISO 15223-1:2016 Ref. 5.4.2
Consult Instructions for use
Prompts the user to consult the user
manual
ISO 15223-1:2016 Ref. 5.4.3
Contains latex
Indicates the presence of natural rubber
latex
ISO 15223-1:2016 Ref. 5.4.5
Caution
Indicates the need to review cautionary
information
ISO 15223-1:2016 Ref. 5.4.4
Humidity Limitation
Indicates the upper and lower limits of
humidity
ISO 15223-1:2016 Ref. 5.3.8
CE Mark
ProductiscertiedforsaleintheEU
Regulation (EC) No. 765/2008 Annex II
Made in the USA
Device was manufactured in the USA
No Standard Applicable
Medical Device
Enclosedequipmentisclassiedasa
medical device
No Standard Applicable
Symbol Glossary
The following glossary describes the symbols included on the device label. Some symbols may not apply
to this device.
3700 Sagamore Parkway North Lafayette, IN 47904
.
Phone: [phone]
6
Gollehon Extendable Goniometer