DEVICE: PENTAX (04961333228324)

Device Identifier (DI) Information

PENTAX
EE-1580K
In Commercial Distribution

HOYA CORPORATION
04961333228324
GS1

1
691519705 *Terms of Use
Perform cleaning, high-level disinfection, and/or sterilization according to the procedure specified in the Instructions for Use (Reprocessing) of this instrument.
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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 video oesophagoscope, reusable An endoscope with a flexible inserted portion intended for the visual examination and treatment of the oesophagus. It is inserted into the body through the mouth. Anatomical images are obtained via a camera incorporated at the distal end of the oesophagoscope and are shown on a monitor. This device is commonly used to examine abnormalities in the tissue structure and mucous lining of the oesophagus. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
FDS Gastroscope and accessories, flexible/rigid
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K961564 000
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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
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

dee7a650-9d72-4805-88c3-f6aad08c666e
July 06, 2018
4
April 07, 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)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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