ABSOLU

GUDID 03700542625521

The ABSolu is a high definition multifunction ophthalmic ultrasound system used for: - Axial Length measurement of the eye by ultrasonic means; - Implanted IOL power calculation, using the axial length measurement; - Visualization of the interior of the eye and the orbit by A and B scans. - ABSOLU S only: Advanced diagnostic - Standardized echography provides detailed information about the internal reflectivity of tissues and allows optimal tissues differentiation, localization and measurement of structures in the eye and orbit.

QUANTEL MEDICAL

Ophthalmic ultrasound imaging system

• Primary Device ID: 03700542625521
• NIH Device Record Key: 2b4fefce-afdb-47cb-afe7-0edb42523ec0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ABSOLU
• Version Model Number: ABSOLU
• Company DUNS: 738574953
• Company Name: QUANTEL MEDICAL
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +33(0)473475475
• Email: contact@quantel-medical.fr

Device Identifiers

Device Issuing Agency	Device ID
GS1	03700542625521 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183414

FDA Product Code

• IYO: System, Imaging, Pulsed Echo, Ultrasonic

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: 2019-07-17
• Device Publish Date: 2019-07-09

Devices Manufactured by QUANTEL MEDICAL

• 03700542625569 - VITRA 2: 2022-01-06 The VITRA 2 is a laser system which emits a treatment beam at 532 nm and is intended for use in photocoagulation of ocular tissu
• 03700542625613 - VITRA 810: 2022-01-06 The Vitra 810 is a laser system which emits a treatment beam at 810 nm and is intended for use in photocoagulation of ocular tis
• 03700542625927 - EASYRET: 2021-10-27 The laser (577 nm Fiber Techology Laser SingleSpot, MultiSpot and Subliminal mode and Slit Lamp Zeiss mode) is a photocoagulator
• 03700542625132 - VITRA: 2021-04-21 Ophthalmic Laser Photocoagulator 532nm MonoSpot Laser Retinal Photocoagulation
• 03700542625286 - SUPRA: 2021-04-21 532nm Ophthalmic Laser System used for Retinal Photocoagulation
• 03700542625316 - SUPRA 577Y: 2021-04-21 577nm Ophthalmic Laser System used for Retinal Photocoagulation
• 03700542625415 - VITRA MULTISPOT: 2021-04-21 532nm Multispot Laser Retinal Photocoagulation
• 03700542625484 - EASYRET: 2021-04-21 577nm Fiber Technology Laser SingleSpot, MultiSpot and SubLiminal mode