DEVICE: FUJIFILM (04547410074093)

Device Identifier (DI) Information

FUJIFILM
DH-17EN
In Commercial Distribution

FUJIFILM CORPORATION
04547410074093
GS1

10
713565195 *Terms of Use
This product is the hood for observation assistance used in combination with our endoscopes in medical facilities.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
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
Endoscope tissue removal cap A sterile plastic tube designed to be placed onto the distal end of an endoscope (e.g., oesophagoscope) to facilitate the removal of coagulated blood/tissue during electrosurgical treatment (e.g., for the treatment of Barrett’s oesophagus). It is designed to fit tightly without fixing, with an oblique leading edge that extends beyond the end of the endoscope to provide atraumatic penetration and scooping functionality, and is available in a range of diameters to accommodate common endoscope diameters. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
FDA Enteroscope and accessories
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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 [?]
High-level Disinfectant
Moist Heat or Steam Sterilization
Ethylene Oxide
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Storage and Handling

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

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Size Type Text
No Device Sizes
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Device Record Status

c52ab8e4-3951-47e3-8e54-137c4147702d
March 29, 2018
2
September 16, 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: 84547410074099 CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+018002728465
xxx@xxx.xxx
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