DEVICE: FIBER ESOPHAGOSCOPE (04961333232741)

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Device Identifier (DI) Information

FIBER ESOPHAGOSCOPE
FE-15W

PENTAX OF AMERICA, INC.
04961333232741
GS1
1
FIBER TRANS N ESOPH (REFURBISHED)
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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 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

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Product Code Product Code Name
GCL Esophagoscope, General & Plastic Surgery
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Sterilization

No
Yes
Sterilization Method [?]
Ethylene Oxide
High-level Disinfectant
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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 Status

Not in Commercial Distribution
April 06, 2017
April 06, 2017
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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)

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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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