AccessGUDID - DEVICE: UroShield Actuaor 10 pack (07290103420123)

GUDID

Device Identifier (DI) Information

Brand Name: UroShield Actuaor 10 pack
Version or Model: 3.0 Actuator
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10-200-0002
Company Name: NANOVIBRONIX INC.

Primary DI Number: 07290103420123
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080326793 *Terms of Use

Device Description: A package of 10 x UroShield disposable Actuators The UroShield is a single catheter use accessory that is clipped on the catheter's external part. After connection to the reusable Driver and activation, Actuator creates surface acoustic waves that cause small acoustic vibrations on the catheter surface to prevent bacteria adhesion to the catheter surface.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	Yes
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?
63693	Urinary catheter ultrasonic bacterial adhesion inhibition system actuator	A non-sterile, portable, noninvasive device designed to generate and deliver ultrasonic vibrations to the external portion of an indwelling urethral catheter to inhibit bacterial attachment/biofilm formation on the catheter surface to reduce risk of infection within the urinary tract. It is a small unit with a transducer and integrated ultrasonic actuator intended to be attached (e.g., clipped onto) the catheter. It is designed to be used with a system control unit (not included) from which it is controlled and draws power. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QMK	Extracorporeal Acoustic Wave Generating Accessory To Urological Indwelling Catheter For Use During The Covid-19 Pandemic

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: 24d75dab-ab88-424e-b373-fafc180429be
Public Version Date: May 12, 2021
Public Version Number: 1
DI Record Publish Date: May 04, 2021