AccessGUDID - DEVICE: UNIVERSAL ENDOSCOPIC ULTRASOUND CENTER (04953170355639)

GUDID

Device Identifier (DI) Information

Brand Name: UNIVERSAL ENDOSCOPIC ULTRASOUND CENTER
Version or Model: EU-ME1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170355639
Issuing Agency: GS1
Commercial Distribution End Date: January 11, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 711789789 *Terms of Use

Device Description: EU-ME1 Universal processor for EUS/EBUS

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
40761	General-purpose ultrasound imaging system	A stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYO	System, imaging, pulsed echo, ultrasonic
ODG	Endoscopic ultrasound system, gastroenterology-urology
ITX	Transducer, ultrasonic, diagnostic
IYN	System, imaging, pulsed doppler, ultrasonic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b8409e15-8b51-40a5-b4cc-d9901a0b25b8
Public Version Date: January 12, 2024
Public Version Number: 6
DI Record Publish Date: September 21, 2016