DEVICE: n.a. (04048551225837)

Device Identifier (DI) Information

n.a.
11101SP2
In Commercial Distribution

Karl Storz GmbH & Co. KG
04048551225837
GS1

1
315731430 *Terms of Use
Rhino-Laryngo-Fiberscope, 2.5 x 370 mm
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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 nasopharyngolaryngoscope An endoscope with a flexible inserted portion intended for the visual examination and treatment of the structures inside the nasal passages, including the sinus openings, the pharyngeal end of the auditory tube, the larynx, and the vocal cords. It is inserted through a nostril and typically provides the operator with greater manoeuvrability (flexibility of the distal end) for improved viewing during nasopharyngolaryngoscopy. 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 [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Liquid Chemical
Peracetic Acid
Hydrogen Peroxide
Ethylene Oxide
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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

dae06b64-d7f1-4abb-b210-a70369d6a449
March 29, 2018
2
September 23, 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)

[?]
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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