DEVICE: Shinypik (06926347905515)
Device Identifier (DI) Information
Shinypik
BV-612
In Commercial Distribution
Shenzhen Brav Electronic Technologies Co., Ltd.
BV-612
In Commercial Distribution
Shenzhen Brav Electronic Technologies Co., Ltd.
The Water floser is used for fushing the oral cavity. The working pnnciple is that wateris pressurized through the pump body to form an ultra-ine high-pressure pulise watercolumn.Composed of a host, water tank, and Jet Tip.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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63585 | Water jet flosser |
An electrically-powered device intended to provide a high-pressure water jet for dental flossing (removal of plaque and/or debris from between teeth) using a dedicated handpiece. It is normally available [non-prescription] over-the-counter (OTC) fo use in the home or healthcare facility.
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FDA Product Code
[?]Product Code | Product Code Name |
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EFS | Unit, Oral Irrigation |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
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No storage/handling found |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
1d58afe0-51d1-4780-8dfd-a9828fb74df9
November 13, 2024
1
November 05, 2024
November 13, 2024
1
November 05, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined