DEVICE: GLO MOUTHGUARD PURPLE (DZ) *I (D7751910231)

Device Identifier (DI) Information

GLO MOUTHGUARD PURPLE (DZ) *I
191-023
In Commercial Distribution
191-023
GREAT LAKES ORTHODONTICS, LTD.
D7751910231
HIBCC

1
041854332 *Terms of Use
GLO MOUTHGUARD PURPLE (DZ) *I
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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
Mouthguard, reusable A prefabricated oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during contact sports, and/or to prevent teeth grinding/clenching (bruxism). It is typically made of standard, preformed materials or items for adaptation to/direct insertion into the mouth; some types are referred to as nightguards or bite raising appliances. This is a reusable device intended for single-patient use.
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FDA Product Code

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Product Code Product Code Name
DYJ Retainer, Screw Expansion, Orthodontic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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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 Record Status

ed355843-5efe-41af-9b53-2d60bb711ac2
September 12, 2018
4
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)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
800-828-7626
info@greatlakesortho.com
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