G&H Orthodontics

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Quality System Certificates

  G&H Medical Device Directive 93/42 EEC
  G&H ISO 13485:2016

  ODP Medical Device Directive 93/42 EEC
  ODP ISO 13485:2016

Declaration of Conformity

  G&H Class I Declaration of Conformity
  G&H Class IIa Declaration of Conformity

  ODP Class I Declaration of Conformity
  ODP Class IIa Declaration of Conformity

  Dentsply Retainer Brite Declaration of Conformity
  Everstick Ortho/A&O Declaration of Conformity
  Gestenco Bite Bumper
  Gestenco Cheek Retractor
  Gestenco Lip Retractor
  Gestenco Smartbond®
  Great Lakes Orthodontics NOLA products
  Ledex Curing Light Declaration of Conformity
  Microbrush Corporation Declaration of Conformity
  Reliance Class I Declaration of Conformity
  Reliance Class IIa Declaration of Conformity

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

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.
	CE 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.
	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.A Effective Date: 2018-03-21

G&H Orthodontics, 2165 Earlywood Drive, Franklin, IN 46131 USA | 317-346-6663 (Fax)

G&H, OrthoForce, OrthoClub, ODP, and the G&H logo are registered trademarks of G&H Wire Company. All other trademarks are property of their respective owner.

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