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Product Label Symbols

REFCatalog Number / "Reference"
This symbol immediately precedes the part number of the product.
 
LOTBatch Code / "Lot"
This symbol immediately precedes the lot number of the product. G&H uses this for part traceability.
EU REPAuthorized Representative in the European Community / "EU Rep"
This symbol immediately precedes the name of our representative within the member states.
Single Use OnlyDo Not Reuse / "Single Use Only"
Devices with this symbol are intended for single use.
HourglassUse 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.
Manufactured ByManufacturer / "Filled Factory"
Symbol for Manufacturer. May also include the date of manufacture in date format YYYY-MM-DD.
Manufacture DateManufactured 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.
Instructions for UseConsult Instructions for Use / "IFU Book"
For products with additional instructions inside the package.
WarningCaution/Warning
Consult Instructions for use for important cautionary information such as warnings and precautions not otherwise presented on the label.
Non-SterileNon–Sterile / "Non–Sterile Triangle"
Not Used: G&H products are only sold non–sterile, therefore do not need to distinguish from sterile.
SunlightKeep away from Sunlight / "Sunlight Warning"
Used on elastics. Product may demonstrate reduced performance / longevity when exposed to sunlight.
LatexContains latex or Presence of Natural Rubber Latex / "Latex Warning"
Used on latex elastics.
TemperatureTemperature 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.
TemperatureTemperature 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.
TemperatureTemperature 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.
CECE Mark
European Conformance to Medical Device Directive 93/42/EEC

0086

CE Class II
Used with the CE mark, the numbers provide reference to our Notified Body.
Chrome NickelNickel and/or Chromium warning
Caution: Product contains Nickel and/or Chromium. To alert of the potential for allergic reactions to these known allergens.
Proposition 65The Safe Drinking Water and Toxic Enforcement Act of 1986 / "Proposition 65"
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.
Rx OnlyFor use or distribution by orthodontic professionals only.
Data MatrixDatmatrix / "Barcode"
Manufacturer code use to contain traceability data of the particular part.
UDI Data MatrixUDI 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
HooksHook
Symbol used to identify brackets that have a hook.
TrashDo Not Dispose in Household Trash
Used for products with batteries or electrical components, cords, chargers, etc.
Sharp WarningSharp
Caution: package contains sharp object.

PRODUCT LABEL SYMBOLS & WARNINGS
Doc. No. - REF.90.005.A
Effective Date: 2018-03-21