DEVICE: Sinuscope (04059082002835)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
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Rigid sinoscope | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the paranasal sinuses during an ear/nose/throat (ENT) intervention. It is inserted through a naris. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. This is a reusable device. |
FDA Product Code
[?]Product Code | Product Code Name |
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EOB | NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K944656 | 000 |
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
842679f9-b3e4-4370-b9bc-b80cecda545a
July 06, 2018
3
September 12, 2016
July 06, 2018
3
September 12, 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
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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
[?]
No Customer Contact currently defined