DEVICE: GL INTRAORAL MOUTH PROPS (D7753006270)

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Device Identifier (DI) Information

GL INTRAORAL MOUTH PROPS
300-627
300-627
GREAT LAKES ORTHODONTICS, LTD.
D7753006270
HIBCC
1
GL INTRAORAL MOUTH PROPS
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Dry-field dental retractor A preassembled device used in orthodontic and restorative dentistry designed to be placed around and inside a patient’s oral cavity to provide the operator with easy access to the field of operation by holding the mouth open and displacing the tongue; it typically allows suction tubing to be connected to permit saliva removal for maintaining a dry oral cavity during treatment procedures (e.g., bonding orthodontic brackets, bleaching, applying veneers or pit and fissure sealants). It is in the form of a synthetic polymer frame and typically consists of cheek retractors, a tongue guard, suction adaptors, and tubing with Y-piece connection to a suction system. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
EIF Accessories, Retractor, Dental
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
May 18, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
No
No
No
No CLOSE

Customer Contact

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800-828-7626
info@greatlakesortho.com
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