DEVICE: MACHIDA (04580137730200)
Device Identifier (DI) Information
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. 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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35204 | Flexible fibreoptic nasopharyngoscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the nasopharynx (the upper part of the throat behind the nose). It is inserted through a nostril during ear/nose/throat (ENT) procedures. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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EQN | Laryngoscope, Nasopharyngoscope |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K821182 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 10 and 40 Degrees Celsius |
Storage Environment Humidity: between 30 and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure: between 700 and 1060 millibar |
Handling Environment Temperature: between 10 and 40 Degrees Celsius |
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure: between 700 and 1060 millibar |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
7450f8a5-55fa-46db-b92c-a0f87790632b
July 06, 2018
3
September 10, 2016
July 06, 2018
3
September 10, 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 |
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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
[?]
No Customer Contact currently defined