Home GUDID B360CS2000 ClearScan®
Primary DI B360CS2000
Brand ClearScan®
Company ESI CORPORATION
Model CS200
Catalog number CS200
Device description ClearScan
Published 2016-09-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile 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 B360CS2001 Package HIBCC 10 In Commercial Distribution B360CS2000 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Body-orifice ultrasound imaging transducer cover, image-enhancement A sheath containing an extraluminal pocket/balloon portion intended to cover an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum), to both protect the transducer and improve image quality. The balloon portion is intended to, when filled with an aqueous solution (e.g., saline), displace air and provide an adjustable interface between the transducer and the anatomy of interest (e.g., prostate) to improve imaging. This is a single-use device.
Regulatory Flags# DUNS number 829391734 Device count 1 Lot or batch true Expiration date on label true No natural rubber latex true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B360011B12360 Prager Ext Set A1236 011B1236 011B1236 2016-09-24 B360011B12630 Prager Ext Set B1263 011B1263 011B1263 2016-09-24 B360PSVGS0 PRAGER SHELL® P106SVGS P106SV GOLD SERIES 2019-12-18 B360P1000 Prager Shell® P-100 P-100 2016-09-24 B360P100AS0 Prager Shell® P-100-AS P-100-AS 2016-09-24 B360P1010 Prager Shell® P-101 P-101 2016-09-24 B360P10120 Prager Shell® P-101-2 P-101-2 2016-09-24 B360P1020 Prager Shell® P-102 P-102 2016-09-24 B360P10220 Prager Shell® P-102-2 P-102-2 2016-09-24 B360P1030 Prager Shell® P-103 P-103 2016-09-24 B360P103GS0 Prager Shell® P-103GS P-103GS 2016-09-24 B360P103SV0 Prager Shell® P-103SV P-103SV 2016-09-24 B360P1040 Prager Shell® P-104 P-104 2016-09-24 B360P104GS0 Prager Shell® P-104GS P-104GS 2016-09-24 B360P104SV0 Prager Shell® P-104SV P-104SV 2016-09-24 B360P1050 Prager Shell® P-105 P-105 2016-09-24 B360P1060 Prager Shell® P-106 P-106 2016-09-24 B360P106GS0 Prager Shell® P-106GS P-106GS 2016-09-24 B360P106SV0 Prager Shell® P-106SV P-106SV 2016-09-24 B360P10720 Prager Shell® P-107-2 P-107-2 2016-09-24
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00850050934233 EndoSound® EVS Probe Endosound, Inc. ITX 2026-06-01 04987670105937 DIAGNOSTIC ULTRASOUND SYSTEM CANON INC. ITX 2026-06-01 04987670106194 DIAGNOSTIC ULTRASOUND SYSTEM CANON INC. ITX 2026-06-01 08800013510112 L8-17H Alpinion Medical Systems Co., Ltd. ITX 2026-05-29 00198953121382 Voluson GE Ultrasound Korea Ltd. ITX 2026-05-28 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 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 08800289970351 cV8 Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD. ITX 2025-02-27
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