COMPACT TOUCH STS

Basic Information

• Brand Name: COMPACT TOUCH STS
• Primary DI: 03700542625026
• Version / Model: COMPACT TOUCH STS UBM
• Company Name: QUANTEL MEDICAL
• Labeler DUNS: 738574953
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: cec73d31-2795-47bf-8f81-4d42452824ad

Device Description

Ophthalmic Ultrasound Biomicroscope UBM and automatic STS measurement for ICL sizing The QUANTEL MEDICAL Compact Touch STS UBMTM Ophthalmic Ultrasound System (and its associated Linear 50 MHz probe) is intended to be used for diagnostic imaging and measurement of the eye including: • Visualization of the interior of the eye by B scans. • Make measurements inside the eye (Sulcus to Sulcus, Irido Cornea Angle Left, Irido Cornea Angle Right, Lens curvature and Anterior Chamber depth).

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	892.1560	2
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	892.1570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11389	Ophthalmic ultrasound imaging system	An assembly of mains electricity (AC-powered) devices designed for ophthalmic imaging procedures. It includes software that supports a variety of static and real-time eye and orbital imaging applications including physical measurement and oncology related treatment. It will generate ultrasound pulses, direct them to a target area, detect the resulting ultrasound echoes, and process the resulting information producing and displaying static or dynamic two- or three-dimensional (3-D) images. This GMDN code includes ultrasound imaging systems with, e.g., A-mode, B-mode, Doppler, colour Doppler (CD), M-mode, and duplex (combination imaging, Doppler and/or colour flow) scanning capabilities.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03700542625026	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]