DEVICE: ULTRASONIC GASTROVIDEOSCOPE (04953170355448)

Device Identifier (DI) Information

ULTRASONIC GASTROVIDEOSCOPE
OLYMPUS GF TYPE UC140P-AL5
In Commercial Distribution

OLYMPUS MEDICAL SYSTEMS CORP.
04953170355448
GS1

1
711789789 *Terms of Use
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 ultrasound gastroduodenoscope An endoscope with a flexible inserted portion, combined with an ultrasound probe, intended for the visual examination and treatment of the upper gastrointestinal (GI) tract [oesophagus, stomach, and duodenum (the first part of the small intestine), including the pancreas and the bile duct]. It is inserted into the body through the mouth during gastroduodenoscopy. Anatomical images are transmitted to the user through a fibreoptic bundle or a video system and the ultrasound probe. The probe may be built-in, or inserted through a dedicated lumen. This device is commonly used to examine structures of the stomach, duodenum, pancreas, and bile duct. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
ITX Transducer, ultrasonic, diagnostic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K011314 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

163aff55-aa1a-4e09-bf79-0bd17d15b44e
October 08, 2018
5
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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Yes
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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