PROBEAM Biometry Probe

Basic Information

• Brand Name: PROBEAM Biometry Probe
• Primary DI: 03700542625101
• Version / Model: TP-02-las
• 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: 3
• Public Version Date: 2018-05-23
• Public Version Status: Update
• Public Device Record Key: b56687d1-bc85-4e6b-a9ee-8e655bfa1554

Device Description

Axial length measurement probe with an integrated laser pointer for biometry: - Ensuring the acquisition in the visual axis - Increasing the patient cooperation - Accelerating the speed of acquisition of A scans

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
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	892.1570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36982	Ophthalmic ultrasound imaging transducer	An ultrasound imaging transducer that is a hand-held device moved over the intact surface of a patient's eye during imaging applications involving the examination of the lens. It may include single or multiple element transducer assembly configurations that convert electric voltages into an ultrasound beam. Typically used with coupling gels to ensure adequate contact with the patient's eye it steers, focuses and detects the ultrasound beam and resulting echoes mechanically or electronically. This group of devices typically includes ultrasound imaging transducers used with A-mode scanning capabilities. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03700542625101	GS1

Customer Contacts

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