DEVICE: STD-ADAPTABLE CLASS III MASK (D7751551220)
Device Identifier (DI) Information
STD-ADAPTABLE CLASS III MASK
155-122
In Commercial Distribution
155-122
GREAT LAKES ORTHODONTICS, LTD.
155-122
In Commercial Distribution
155-122
GREAT LAKES ORTHODONTICS, LTD.
STD-ADAPTABLE CLASS III MASK
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Orthodontic extraoral headgear | A dental device used in conjunction with orthodontic appliances to exert pressure on the teeth or the jaws from outside the mouth. An orthodontic headgear will typically have a strap that wraps around the patient's neck or head and an inner bow portion that is fastened to the orthodontic appliance in the patient's mouth, or utilizes rests on the chin and forehead (reverse pull headgear). |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DZB | Headgear, Extraoral, Orthodontic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
57559185-bc45-4d5d-bac0-8c1db061e507
March 29, 2018
2
May 18, 2016
March 29, 2018
2
May 18, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
8008287626
info@greatlakesortho.com
info@greatlakesortho.com