DEVICE: EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE (04953170356346)

Device Identifier (DI) Information

EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
OLYMPUS GF TYPE UCT180
In Commercial Distribution

OLYMPUS MEDICAL SYSTEMS CORP.
04953170356346
GS1

1
711789789 *Terms of Use
No description.
CLOSE

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 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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
ODG Endoscopic ultrasound system, gastroenterology-urology
ITX Transducer, ultrasonic, diagnostic
IYN System, imaging, pulsed doppler, ultrasonic
IYO System, imaging, pulsed echo, ultrasonic
NWB Endoscope, accessories, narrow band spectrum
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K093395 000
No CLOSE

Sterilization

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

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

0b931c3a-df32-4556-b45c-5e5d30cd4de8
July 06, 2018
3
September 21, 2016
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+1(800)401-1086
xx@xx.xx
CLOSE