AccessGUDID - DEVICE: Sonata® Intrauterine Ultrasound Probe (30817929020092)

GUDID

Device Identifier (DI) Information

Brand Name: Sonata® Intrauterine Ultrasound Probe
Version or Model: IUSP-002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: IUSP-002
Company Name: Gynesonics, Inc.

Primary DI Number: 30817929020092
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 618493741 *Terms of Use

Device Description: Ultrasound-guided intrauterine electrosurgical diathermy system intrauterine ultrasound transducer

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?
64389	Ultrasound-guided intrauterine radio-frequency ablation system intrauterine ultrasound transducer, reusable	A component of an ultrasound-guided intrauterine radio-frequency (RF) ablation system designed to convert electric voltages into an ultrasound beam to produce intrauterine ultrasound images used to monitor/guide electrosurgical procedures. It is typically used as part of a dedicated handpiece and is inserted transcervically into the uterus where it is intended to be manually manoeuvred to steer/focus the ultrasound beam for visualization of uterine pathology (e.g., fibroids). This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITX	Transducer, Ultrasonic, Diagnostic
KNF	Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)

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: Yes

Sterilization Method [?]
Hydrogen Peroxide
Ethylene Oxide
Liquid Chemical

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -20 and 40 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 18a70b4a-126c-4a51-b3a6-f7251ba9a7fa
Public Version Date: May 26, 2025
Public Version Number: 5
DI Record Publish Date: May 10, 2019