HistoSonics

GUDID 00850006962273

Treatment Head, 14 cm

Histosonics, Inc.

Therapeutic oncological/gynaecological ultrasound system

• Primary Device ID: 00850006962273
• NIH Device Record Key: 04d9536c-44c6-426a-a0da-080ff8e6f29d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HistoSonics
• Version Model Number: EDNTH14
• Company DUNS: 028153599
• Company Name: Histosonics, 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: 8777400543
• Email: info@histosonics.com
• Phone: 8777400543
• Email: info@histosonics.com
• Phone: 8777400543
• Email: info@histosonics.com
• Phone: 8777400543
• Email: info@histosonics.com
• Phone: 8777400543
• Email: info@histosonics.com
• Phone: 8777400543
• Email: info@histosonics.com
• Phone: 8777400543
• Email: info@histosonics.com
• Phone: 8777400543
• Email: info@histosonics.com
• Phone: 8777400543
• Email: info@histosonics.com
• Phone: 8777400543
• Email: info@histosonics.com
• Phone: 8777400543
• Email: info@histosonics.com
• Phone: 8777400543
• Email: info@histosonics.com

Device Dimensions

• Depth: 14 Centimeter
• Depth: 14 Centimeter
• Depth: 14 Centimeter
• Depth: 14 Centimeter
• Depth: 14 Centimeter
• Depth: 14 Centimeter
• Depth: 14 Centimeter
• Depth: 14 Centimeter
• Depth: 14 Centimeter
• Depth: 14 Centimeter
• Depth: 14 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -15 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850006962273 [Primary]

FDA Product Code

• QGM: Focused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-12
• Device Publish Date: 2026-02-04

On-Brand Devices [HistoSonics]

• 00850006962129: Histotripsy Procedure Kit
• 00850006962075: Fluidics Disposable Kit
• 00850006962068: Fluidics Cart
• 00850006962280: Treatment Head, 12cm
• 00850006962273: Treatment Head, 14 cm