Home GUDID 00896100002088 PacScan 300 Plus Ophthalmic Ultrasound
Primary DI 00896100002088
Brand PacScan 300 Plus Ophthalmic Ultrasound
Company SONOMED, INC.
Model 300A+ A-Scan Only
Catalog number 300A+
Device description "The PacScan 300 Plus ophthalmic ultrasound system is a non-invasive, active device intended for imaging ocular features for diagnostic purposes. The A-Scan system allows for measuring the axial length (AXL), anterior chamber depth, and lens thickness of an eye and for calculating the associated IOL power for an implanted lens. The 300A+ A-Scan model can be used to collect scan data using the direct contact or immersion method. There are five examination modes: Cataract, Dense Cataract, Aphakic, Pseudophakic and 4-Gate Manual. The PacScan 300A+ system includes a 6"" color LCD, touch screen, built-in thermal printer, 10 MHz A-probe, foot switch and operator manual."
Published 2016-08-10
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name ITX Transducer, Ultrasonic, Diagnostic
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ITX Transducer, Ultrasonic, Diagnostic Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00896100002088 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00896100002088 00896100002088 896100002088 0896100002088
GMDN Terms# Term, Definition table Term Definition 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.
Regulatory Flags# DUNS number 107037079 Device count 1 Lot or batch true Serial number true Manufacturing date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00896100002002 AXIS Image Management System Ver 5 Axis 2022-03-21 00896100002019 VuPad Ophthalmic Ultrasound System VuPad AP AP.580 2020-12-07 00896100002026 VuPad Ophthalmic Ultrasound System VuPad BP BP.580 2020-12-07 00896100002033 VuPad Ophthalmic Ultrasound System VuPad A/B/P BAP.580 2020-12-07 00896100002040 VuPad Ophthalmic Ultrasound System VuPad UBM/P UP.580 2020-12-07 00896100002057 VuPad Ophthalmic Ultrasound System VuPad B/UBM/P BUP.580 2020-12-07 00896100002064 VuPad Ophthalmic Ultrasound System VuPad A/B/UBM/P BUAP.580 2020-12-07 00896100002125 VuPad Ophthalmic Ultrasound System VuPad B B.580 2016-08-10 00896100002132 VuPad Ophthalmic Ultrasound System VuPad A/B BA.580 2016-08-10 00896100002149 VuPad Ophthalmic Ultrasound System VuPad UBM U.580 2016-08-10 00896100002156 VuPad Ophthalmic Ultrasound System VuPad B/UBM BU.580 2016-08-10 00896100002163 VuPad Ophthalmic Ultrasound System VuPad A/B/UBM BUA.580 2016-08-10 00896100002170 VuPad Ophthalmic Ultrasound System VuPad A A.580 2016-08-10 00896100002095 PacScan 300 Plus Ophthalmic Ultrasound 300AP+ A-Scan/Pachymeter 300AP+ 2016-08-10 00896100002101 Master-Vu A-Scan Ophthalmic Ultrasound System MV4500 MV4500 2016-08-10 00896100002118 Master-Vu B-Scan Ophthalmic Ultrasound System MV5600 MV5600 2016-08-10 00896100002187 VuMAX HD Ophthalmic Ultrasound System VuMAX HD B Scan B.575 2016-08-10 00896100002194 VuMAX HD Ophthalmic Ultrasound System VuMAX-HD UBM U.575 2016-08-10 00896100002200 VuMAX HD Ophthalmic Ultrasound System VuMAX HD A/B BA.575 2016-08-10 00896100002217 VuMAX HD Ophthalmic Ultrasound System VuMAX HD A/B/UBM BUA.575 2016-08-10
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 08800290027266 PA2-9S SAMSUNG MEDISON CO., LTD. ITX 2026-04-03 08800290027419 LA2-9SD SAMSUNG MEDISON CO., LTD. ITX 2026-04-03 08800290028638 CA2-8AD SAMSUNG MEDISON CO., LTD. ITX 2026-04-03 08800290029390 EV2-10A SAMSUNG MEDISON CO., LTD. ITX 2026-04-03 08800290029420 CV1-8AE SAMSUNG MEDISON CO., LTD. ITX 2026-04-03 08800290029512 LA3-16AD SAMSUNG MEDISON CO., LTD. ITX 2026-04-03 08800290029604 L3-22 SAMSUNG MEDISON CO., LTD. ITX 2026-04-03 08800290029611 LA3-22AI SAMSUNG MEDISON CO., LTD. ITX 2026-04-03 08800290029741 EA2-11AVE SAMSUNG MEDISON CO., LTD. ITX 2026-04-03 08800290029789 EA2-11ARE SAMSUNG MEDISON CO., LTD. ITX 2026-04-03 08800290029826 CA4-10M SAMSUNG MEDISON CO., LTD. ITX 2026-04-03 08800290027471 EV2-12 SAMSUNG MEDISON CO., LTD. ITX 2026-01-28 08800289975974 R30 Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD. ITX 2026-01-20 08800289976025 R20 Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD. ITX 2026-01-20 08800289979224 EA2-11ARn SAMSUNG MEDISON CO., LTD. ITX 2026-01-20 08800289979262 CA1-7Sn SAMSUNG MEDISON CO., LTD. ITX 2026-01-20 08800290027297 PA2-9S SAMSUNG MEDISON CO., LTD. ITX 2026-01-20 08800290027334 LA2-9Sn SAMSUNG MEDISON CO., LTD. ITX 2026-01-20 08800290027365 CA3-10An SAMSUNG MEDISON CO., LTD. ITX 2026-01-20 08056304455826 MyLabC25 ESAOTE SPA ITX 2025-12-10 08056304455833 MyLabC30 ESAOTE SPA ITX 2025-12-10 08800289979132 cV4 Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD. ITX 2025-09-03 08800289981883 cV5 Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD. ITX 2025-09-03 08056304455017 MyLabA50 ESAOTE SPA ITX 2025-07-07 08056304455215 MyLabE85 ESAOTE SPA ITX 2025-07-07 08056304455307 MyLabA70 ESAOTE SPA ITX 2025-07-07 08056304455437 MyLabA50 ESAOTE SPA ITX 2025-07-07 08056304455451 MyLabA70 ESAOTE SPA ITX 2025-07-07 08056304455635 MyLabE80 ESAOTE SPA ITX 2025-07-07 08056304455642 MyLabE85 ESAOTE SPA ITX 2025-07-07