AccessGUDID - DEVICE: Sonata® SMART Tablet (10817929020197)

GUDID

Device Identifier (DI) Information

Brand Name: Sonata® SMART Tablet
Version or Model: USCON-2200
Commercial Distribution Status: In Commercial Distribution
Catalog Number: USCON-2200
Company Name: Gynesonics, Inc.

Primary DI Number: 10817929020197
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 system ultrasound control unit

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?
58489	Ultrasound-guided intrauterine radio-frequency ablation system ultrasound control unit	A mains electricity (AC-powered) component of an ultrasound-guided intrauterine electrosurgical system designed to provide ultrasound imaging via a transvaginal and intrauterine ultrasound imaging transducer. The imaging is used to guide the radio-frequency (RF) ablation treatment. It typically consists of a laptop computer with an embedded ultrasound engine and installed graphical user interface software, which provides standard ultrasound controls and procedure-specific guidance for fibroid ablation planning, targeting, and procedural workflow.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYO	System, Imaging, Pulsed Echo, Ultrasonic
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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -20 and 45 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: 0050efa6-cff2-4269-93ea-196cafa3d2e2
Public Version Date: May 26, 2025
Public Version Number: 4
DI Record Publish Date: May 10, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 650-216-3860
Email: customersupport@gynesonics.com

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