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AJ Wilcock® Australian Wire
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Quality
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Quality System Certificates
Notified Body Migration of Certificates
NEW
G&H Medical Device Directive 93/42 EEC
G&H ISO 13485:2016
ODP Medical Device Directive 93/42 EEC
ODP ISO 13485:2016
OrthoClub Medical Device Directive 93/42 EEC
OrthoClub ISO 13485:2016
FlexMedics Medical Device Directive 93/42 EEC
FlexMedics ISO 13485:2016
Declaration of Conformity
G&H Class I
G&H Class IIa
G&H Class IIa
NEW
ODP Class I
ODP Class IIa
ODP Class IIa
NEW
OrthoClub Class I
OrthoClub Class IIa
OrthoClub Class IIa
NEW
FlexMedics Class I
FlexMedics Class IIa
FlexMedics Class IIa
NEW
Dentsply Retainer Brite
Everstick Ortho/A&O
Gestenco Bite Bumper
Gestenco Cheek Retractor
Gestenco Lip Retractor
Gestenco Smartbond®
Great Lakes Orthodontics NOLA products
Ledex Curing Light
Microbrush Corporation
Reliance Class I
Reliance Class IIa
Material Safety Data Sheets
View Material Safety Data Sheets
Instructions for Use
Enforce frc™ Application
EverStick® ORTHO Application
Ledex™ Curing Light
Porc-Etch™ and Porcelain Conditioner
Sterilization - Photography Mirrors
Sterilization - Orthodontic Pliers
These documents are in PDF format which utilize the Adobe® Reader. If you do not have the updated version,
download a free copy
. Click link to view document or right-click on the link to select option to save.
Product Label Symbols
Catalog Number / "Reference"
This symbol immediately precedes the part number of the product.
Batch Code / "Lot"
This symbol immediately precedes the lot number of the product. G&H uses this for part traceability.
Authorized Representative in the European Community / "EU Rep"
This symbol immediately precedes the name of our representative within the member states.
Do Not Reuse / "Single Use Only"
Devices with this symbol are intended for single use.
Use By / "Hourglass"
This symbol identifies that the part has a "Use by" date. The part should be used prior to the date located next to this symbol. Date format
YYYY-MM-DD
, i.e. 2018-03-08.
Manufacturer / "Filled Factory"
Symbol for Manufacturer. May also include the date of manufacture in date format
YYYY-MM-DD
.
Manufactured Date / "Open Factory"
Date of manufacture listed under or beside this symbol in
YYYY-MM-DD
format. Note: Used only when the "filled factory" symbol is not present.
Consult Instructions for Use / "IFU Book"
For products with additional instructions inside the package.
Caution/Warning
Consult Instructions for use for important cautionary information such as warnings and precautions not otherwise presented on the label.
Non–Sterile / "Non–Sterile Triangle"
Not Used: G&H products are only sold non–sterile, therefore do not need to distinguish from sterile.
Keep away from Sunlight / "Sunlight Warning"
Used on elastics. Product may demonstrate reduced performance / longevity when exposed to sunlight.
Contains latex or Presence of Natural Rubber Latex / "Latex Warning"
Used on latex elastics.
Temperature Upper Limit
Controlled storage is required. Number indicated to the right is the max (highest) temperature at which device should be stored in, or exposed to.
Temperature Lower Limit
Controlled storage is required. Number indicated to the left is the min (lowest) temperature at which device should be stored in, or exposed to.
Temperature Limit
Controlled storage is required. Number indicated to lower left is the min (lowest) temperature, and number indicated to upper right is the max (highest) temperature at which the device should be stored in, or exposed to.
Medical Device
This symbol indicates the product is a medical device.
CE Mark
European Conformance to Medical Device Directive 93/42/EEC
0086
Notified Body Identification Number
BSI Healthcare
Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes, MK5 8PP,
United Kingdom
2797
Notified Body Identification Number
BSI Group The Netherlands B.V.
Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, Netherlands
Nickel and Chromium warning
Caution: Product contains Nickel and Chromium. To alert of the potential for allergic reactions to these known allergens.
Chromium warning
Caution: Product contains Chromium. To alert of the potential for allergic reactions to these known allergens.
The Safe Drinking Water and Toxic Enforcement Act of 1986 / "Proposition 65"
Nickel and Chromium
This product can expose you to chemicals including nickel and chromium, which are known to the State of California to cause cancer, and chromium, which is known to the State of California to cause birth defects or other reproductive harm. For more information go to
www.P65Warnings.ca.gov
.
Chromium
This product can expose you chromium, which is known to the State of California to cause cancer, birth defects or other reproductive harm. For more information go to
www.P65Warnings.ca.gov
.
For use or distribution by orthodontic professionals only.
Datmatrix / "Barcode"
Manufacturer code use to contain traceability data of the particular part.
UDI Datmatrix / "UDI Barcode"
Manufacturer Unique Device Identifier "UDI" code used to contain traceability data of the particular part to meet requirement of
FDA CFR 820.120
Hook
Symbol used to identify brackets that have a hook.
Do Not Dispose in Household Trash
Used for products with batteries or electrical components, cords, chargers, etc.
Sharp
Caution: package contains sharp object.
Corrosive Warning (Class 8)
Used to denote a corrosive material which is a liquid or solid that causes full thickness destruction of human skin at the site of contact within a specified period of time.
PRODUCT LABEL SYMBOLS & WARNINGS
Doc. No. - REF.90.005.C
Effective Date: 2019-11-22
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