AccessGUDID - DEVICE: COMPACT TOUCH STS (03700542625026)

GUDID

Device Identifier (DI) Information

Brand Name: COMPACT TOUCH STS
Version or Model: COMPACT TOUCH STS UBM
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: QUANTEL MEDICAL

Primary DI Number: 03700542625026
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 738574953 *Terms of Use

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

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):	No
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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYO	System, Imaging, Pulsed Echo, Ultrasonic
ITX	Transducer, Ultrasonic, Diagnostic

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cec73d31-2795-47bf-8f81-4d42452824ad
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016