DEVICE: ENTity XL Nasopharyngoscope (00085119004132)

Device Identifier (DI) Information

ENTity XL Nasopharyngoscope
F014721
In Commercial Distribution

OPTIM LLC
00085119004132
GS1

1
052927001 *Terms of Use
ENTity XL NasoView Flexible LED Nasopharyngoscope
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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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FDA Product Code

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Product Code Product Code Name
EOB Nasopharyngoscope (Flexible Or Rigid)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K080622 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

9428d2a6-137d-4d80-b58c-8824febc0dfb
July 06, 2018
3
September 19, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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