AccessGUDID - DEVICE: EndoSound® Ultrasound Transducer Module (UTM) (00850050934165)

GUDID

Device Identifier (DI) Information

Brand Name: EndoSound® Ultrasound Transducer Module (UTM)
Version or Model: 5016
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5016
Company Name: Endosound, Inc.

Primary DI Number: 00850050934165
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 111281644 *Terms of Use

Device Description: EndoSound Ultrasound Transducer Module (UTM) converts the electrical signals from the EVSScanner into ultrasound energy.

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 [?]
K232518	000

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
Handling Environment Atmospheric Pressure: between 75 and 106 KiloPascal
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 60 Degrees Celsius
Storage Environment Atmospheric Pressure: between 75 and 106 KiloPascal
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between -10 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b2eb1f89-c5c6-4600-a2a0-3e780c7e8755
Public Version Date: November 08, 2024
Public Version Number: 1
DI Record Publish Date: October 31, 2024