DEVICE: FUJIFILM (04547410330977)

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Device Identifier (DI) Information

FUJIFILM
ES-450WE5

FUJIFILM CORPORATION
04547410330977
GS1
1
This product is a medical Endoscope for the lower digestive tract. It is intended for observation, diagnosis, and endoscopic treatment of the rectum and large intestine at medical facilities under management of physicians.
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
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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 video sigmoidoscope An endoscope with a flexible inserted portion intended for the visual examination and treatment of the sigmoid colon (the distal S-shaped part of the large intestine leading to the rectum). It is inserted through the anus during sigmoidoscopy or proctosigmoidoscopy. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope and the images showing on a monitor. This device is commonly used to examine the structures and lining of the sigmoid colon and for indications of altered bowel habit, colonic cancer, or polyps. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
FAM sigmoidoscope and accessories, flexible/rigid
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Sterilization

No
Yes
Sterilization Method [?]
High-level Disinfectant
Ethylene Oxide
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Special Storage Condition, Specify: There must be no condensation.
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
December 14, 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
14547410330974 1 04547410330977 In Commercial Distribution Box
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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
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Yes
No CLOSE

Customer Contact

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+018002728465
xxx@xxx.xxx
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