Symbols glossary (updated in accordance with ISO 15223-1:2021)
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SYMBOL
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TITLE
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Designation number
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Explanatory text
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Standard
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Manufacturer
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5.1.1.
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Indicates the medical device manufacturer, as defined in ISO 15223:2021.
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* Yes
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Date of manufacture
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5.1.3.
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Indicates the date when the medical device was manufactured
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* Yes
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Use-by date
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5.1.4.
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Indicates the date after which the medical device is not to be used.
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* Yes
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Batch code
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5.1.5.
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Indicates the manufacturer’s batch code so that the batch or lot can be identified.
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* Yes
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Catalogue number
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5.1.6.
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Indicates the manufacturer’s catalogue number so that the medical device can be identified.
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* Yes
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Temperature limit
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5.3.7.
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Indicates the temperature limits to which the medical device can be safely exposed.
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* Yes
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Do not re-use
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5.4.2.
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Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure.
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* Yes
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Consult instructions for use
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5.4.3.
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Indicates the need for the user to consult the instructions for use.
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* Yes
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Caution
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5.4.4.
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Indicates that caution is necessary when operating the device or control close to where the symbol is placed, or that current situation needs operator awareness or operator action in order to avoid undesirable consequences.
This symbol shall not be used to solely mean “consult instructions for use”. |
* Yes
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Medical Device
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5.5.7
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Indicates the item is a medical device
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* Yes
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Prescription Use Only
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21CFR 801.109
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Caution: Federal (USA) law restricts this device to sale by or on the order of a dentist.
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No
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Radiopaque
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-
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The material is radiopaque.
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No
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Liquid
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-
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Bottle with Ceramir Crown & Bridge QuikMix Liquid
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No
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Powder
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-
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Jar with Ceramir Crown & Bridge QuikMix Powder
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No
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Scoop
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-
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Scoop to be used when dosing Ceramir Crown & Bridge QuikMix powder.
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No
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Mixing pad
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-
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Mixing pad delivered together with Ceramir Crown & Bridge QuikMix that can be used for mixing the cement.
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No
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Capsule
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-
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Indicates, together with a figure, the number of capsules in the package
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No
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No Pre-treatment
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-
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Do not use any pre-treatment agents, e.g. silanes, primers or bonding agents when cementing with Ceramir Crown & Bridge or Ceramir Bioceramic Implant Cement. Use of any such pre-treatments may compromise the bonding of the cement.
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No
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* ISO 15223-1:2021, not yet recognized by FDA.
Recognition Number 5-117: ISO 15223-1 Third Edition 2016-11-01, Medical devices - symbols to be used with medical device labels, labelling, and information to be supplied - part 1: General requirements.
Recognition Number 5-117: ISO 15223-1 Third Edition 2016-11-01, Medical devices - symbols to be used with medical device labels, labelling, and information to be supplied - part 1: General requirements.
