DEVICE: EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE (04953170339936)

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Device Identifier (DI) Information

EVIS EXERA II SMALL INTESTINAL VIDEOSCOPE
OLYMPUS SIF TYPE Q180

OLYMPUS MEDICAL SYSTEMS CORP.
04953170339936
GS1
1
No description.
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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 video enteroscope An endoscope with a flexible inserted portion intended for the visual examination and treatment of the small intestine (the duodenum, jejunum, and ileum). It is inserted into the body through the mouth or the anus during enteroscopy. It may be of a push-type, introduced by guidance under direct vision, or of a sonde type, which has an inflatable balloon that pulls it through the length of the intestine by peristalsis. 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 reusable device is used to examine strictures, Crohn's disease, or take biopsies.
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FDA Product Code

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Product Code Product Code Name
FED endoscopic access overtube, gastroenterology-urology
FDA Enteroscope and accessories
NWB Endoscope, accessories, narrow band spectrum
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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

In Commercial Distribution
September 21, 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
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
Yes
No CLOSE

Customer Contact

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+1(800)401-1086
xx@xx.xx
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