AccessGUDID - DEVICE: 4 MHz probe (07290016880397)

GUDID

Device Identifier (DI) Information

Brand Name: 4 MHz probe
Version or Model: 4 MHz probe
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PVC0330
Company Name: VIASONIX LTD

Primary DI Number: 07290016880397
Issuing Agency: GS1
Commercial Distribution End Date: December 24, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 533070236 *Terms of Use

Device Description: 4 MHz probe is an ultrasonic transducer that generates acoustic signals and also detects returned signals, intended to be used in combination with the Falcon system for noninvasive peripheral vascular measurements.

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
JOP	Transducer, Ultrasonic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K111416	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 889c8287-081d-4944-869d-ce082d7ce380
Public Version Date: August 16, 2022
Public Version Number: 1
DI Record Publish Date: August 08, 2022