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ADVERSE EFFECTS
Adverse effects are not expected as long as the
product is used in accordance with its instructions
for use.
POST-OPERATIVE PRECAUTIONS AND
MAINTENANCE
Instruct the patient as to the need for a
professional medical monitoring after the
surgery and to obey the guidelines regarding
the precautions, hygiene and prescription of
drugs. Evaluate the need for follow-up with
periodic clinical appointments and radiographic
examinations. The professional in charge is
responsible for providing these guidelines.
STORAGE CONDITIONS
This product must be stored, in its original
packaging, in a clean and dry location, at room
temperature and protected from direct sunlight.
DISPOSAL OF MATERIAL
All products and consumables used during the
surgery for the installation of dental implants may
endanger the health of anyone who handles them.
Before discarding them into the environment, it is
recommended to observe the current legislation
and adhere to it.
DATE OF EXPIRATION
Written on the label.
LIFE CYCLE
This product is recommended for up to 100 uses
as long as Neodent recommended conditions of
use are respected.
Regardless of the amount of times the instrument
has been used, the professional must always
evaluate its conditions before/after each use.
Visually inspect the lid, tray, and case bottom to
ensure there is no cracking, deformation, or other
damage.
Visually inspect that all labeling printed on the lid
and tray is clear and legible.
Verify that the lid, tray, and case bottom can be
assembled and that the lid latches securely to the
case bottom.
Do not use the Kit Case if any of the above or
any other damage is observed, regardless of the
amount of cycles of use.
Each instrument has its own recommendations of
amount of cycles. Please consult the instructions
for use from the instruments that integrate the
Kit and replace them accordingly.
SYMBOLS
The table describes the symbols that may be
printed on the product labeling. Please, refer to
the physical labeling to see which symbols are
applicable to the product.
Symbols
Description
Product size
Catalog number
Batch code
Serial number
Product manufacturing material
UDI code
704021.03
Symbols
Description
Medical device
Date of manufacture
Manufacturer
Use-by date
Quantity
Consult instructions for use
Reprocessing forbidden
Sterilized using ethylene oxide
Sterilized using irradiation
Do not reuse
Do not use if package is damaged
Do not resterilize
Fragile
Upper limit of temperature
Keep dry
Keep away from sunlight
Authorized representative in the
European Community
Importer in the European Community
Swiss Authorised Representative
Single sterile barrier system
Single sterile barrier system with
protective packaging inside
Notification required by FDA for United
States market
CE Mark
Non-sterile
© 2021 — JJGC Indústria e Comércio de Materiais
Dentários S.A. All rights reserved.
ENZOL® is a registered trademark of Johnson &
Johnson.
Federal (USA) law restricts this device to sale by
or on the order of a licensed dentist or physician.
Not all products are available in all countries.
Please, contact the authorized distributor.
GM Easy Guide Surgical Kit Case Narrow/Regular
Valid for the USA
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