Sonata® Intrauterine Ultrasound Probe IUSP-002

GUDID 30817929020092

Ultrasound-guided intrauterine electrosurgical diathermy system intrauterine ultrasound transducer

GYNESONICS, INC.

Ultrasound-guided intrauterine radio-frequency ablation system intrauterine ultrasound transducer, reusable

Primary Device ID	30817929020092
NIH Device Record Key	18a70b4a-126c-4a51-b3a6-f7251ba9a7fa
Commercial Distribution Status	In Commercial Distribution
Brand Name	Sonata® Intrauterine Ultrasound Probe
Version Model Number	IUSP-002
Catalog Number	IUSP-002
Company DUNS	618493741
Company Name	GYNESONICS, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10817929020098 [Direct Marking]
GS1	30817929020092 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K173703

FDA Product Code

ITX	Transducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[30817929020092]

Hydrogen Peroxide;Ethylene Oxide

[30817929020092]