AccessGUDID - DEVICE: ULTRASONIC PROBE (04953170368585)

GUDID

Device Identifier (DI) Information

Brand Name: ULTRASONIC PROBE
Version or Model: UM-BS20-26R
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170368585
Issuing Agency: GS1
Commercial Distribution End Date: August 10, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 711789789 *Terms of Use

Device Description: "UM-BS20-26R-3(E) ULTRASONIC PROBE"

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?
64359	Flexible endoscopic ultrasound imaging transducer	A flexible, ultrasound imaging transducer assembly designed to be to be inserted through the working channel of an appropriate flexible endoscope and positioned within the gastrointestinal, respiratory or urinary tract, (i.e., application is not specific to any particular anatomy) to transmit a signal/data to another device for display. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITX	Transducer, ultrasonic, diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K944610	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Ethylene Oxide
High-level Disinfectant

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: d70639c5-53c0-439d-b5ed-cabd30a581eb
Public Version Date: April 22, 2024
Public Version Number: 10
DI Record Publish Date: September 21, 2016