AccessGUDID - DEVICE: EndoSound® EVS™ Bands (00850050934141)

GUDID

Device Identifier (DI) Information

Brand Name: EndoSound® EVS™ Bands
Version or Model: 18102
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5013
Company Name: Endosound, Inc.

Primary DI Number: 00850050934141
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 111281644 *Terms of Use

Device Description: EndoSound® EVS™ Bands, is a disposable, single-use kit used to attach the UTM to compatible endoscopes.

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:	Yes
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
ODG	Endoscopic Ultrasound System, Gastroenterology-Urology
IYN	System, Imaging, Pulsed Doppler, Ultrasonic
IYO	System, Imaging, Pulsed Echo, Ultrasonic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K232518	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between -10 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 9.5 Millimeter
Device Size Text, specify: 1.25mm wall thickness

Device Record Status

Public Device Record Key: 848c5a35-870f-412f-b060-3b26bf38e1c6
Public Version Date: June 24, 2024
Public Version Number: 1
DI Record Publish Date: June 14, 2024