DEVICE: FUJIFILM (04547410330977)
Device Identifier (DI) Information
FUJIFILM
ES-450WE5
In Commercial Distribution
FUJIFILM CORPORATION
ES-450WE5
In Commercial Distribution
FUJIFILM CORPORATION
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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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17664 | Flexible video sigmoidoscope, reusable |
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), typically in relation to altered bowel habit, colonic cancer, or polyps. It is inserted through the anus during sigmoidoscopy or proctosigmoidoscopy. Anatomical images are transmitted to the user by a video system with an image sensor chip at the distal end of the endoscope and the images showing on a monitor. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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FAM | sigmoidoscope and accessories, flexible/rigid |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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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 |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
71d64b50-5ba4-4921-ba6f-4619827930bc
November 17, 2023
3
December 14, 2016
November 17, 2023
3
December 14, 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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14547410330974 | 1 | 04547410330977 | In Commercial Distribution | Box |
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
[?]
+018002728465
xxx@xxx.xxx
xxx@xxx.xxx