AccessGUDID - DEVICE: UroNav (00884838107069)

GUDID

Device Identifier (DI) Information

Brand Name: UroNav
Version or Model: UroNav 4
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 784039
Company Name: Philips DS North America LLC

Primary DI Number: 00884838107069
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118983916 *Terms of Use

Device Description: UroNav is a medical image processing device that provides image-guided intervention and diagnostic information, which guides interventional instrumentation to targets that have been defined by the physician.

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?
40873	Ultrasound imaging system application software	An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a diagnostic ultrasound system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software programs or program packages must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LLZ	System, Image Processing, Radiological
QTZ	Radiological Image Processing Software For Ablation Therapy Planning And Evaluation

FDA Premarket Submission

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

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
Storage Environment Temperature: between 5 and 55 Degrees Celsius
Handling Environment Temperature: between 5 and 55 Degrees Celsius
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Special Storage Condition, Specify: Fragile
Special Storage Condition, Specify: Do not stack
Special Storage Condition, Specify: This way up
Special Storage Condition, Specify: Keep away from rain

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 107d1cd3-72ef-4544-9700-57c154ef635a
Public Version Date: June 16, 2025
Public Version Number: 7
DI Record Publish Date: July 22, 2022