DEVICE: HOPKINS (04048551193419)
Device Identifier (DI) Information
HOPKINS
7228AA
In Commercial Distribution
Karl Storz GmbH & Co. KG
7228AA
In Commercial Distribution
Karl Storz GmbH & Co. KG
HOPKINS® Telescope 0°, 4 mm, 15 cm
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
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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35316 | Rigid optical rhinoscope |
An endoscope with a rigid inserted portion intended for the visual examination and treatment of the nasal cavity and/or nasopharynx. It is inserted into the body through a nostril or the oral cavity during rhinoscopy or an ear/nose/throat (ENT) intervention. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. Also referred to as a nasoscope or nasal endoscope, it is typically used during the removal of the adenoids (glandular tissue in the nasopharynx, also known as the pharyngeal tonsils). This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EOB | NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K945788 | 000 |
Sterilization
No
Yes
CLOSE
Yes
Sterilization Method [?] |
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Ethylene Oxide |
Hydrogen Peroxide |
Moist Heat or Steam 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
b52a3a7f-cd5f-4aba-9da5-1bc055e337a4
November 17, 2023
5
September 23, 2016
November 17, 2023
5
September 23, 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