DEVICE: n.a. (04048551227473)

Device Identifier (DI) Information

n.a.
13304C1
In Commercial Distribution

Karl Storz GmbH & Co. KG
04048551227473
GS1

1
315731430 *Terms of Use
Pharyngo-Esophago-Fiberscope, 3.5 x 76
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Flexible fibreoptic oesophagoscope An endoscope with a flexible inserted portion intended the visual examination and treatment of the oesophagus. It is inserted into the body through the mouth. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used to examine abnormalities in the tissue structure and mucous lining. This is a reusable device.
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FDA Product Code

[?]
Product Code Product Code Name
EOX ESOPHAGOSCOPE (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 [?]
Hydrogen Peroxide
Peracetic Acid
Liquid Chemical
Ethylene Oxide
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Storage and Handling

[?]
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

7a48f338-4127-421d-a56f-677ee5dea4a0
March 29, 2018
2
September 23, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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