FDA.reportPublic FDA data

UST-5543

Primary DI
04573596212899
Brand
UST-5543
Company
FUJIFILM HEALTHCARE CORPORATION
Model
UST-5543
Device description
Probe
Published
2021-07-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04562122954952PreviousGS10
04573596212899PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04562122954952045621229549524562122954952
04573596212899045735962128994573596212899

GMDN Terms#

Term, Definition table
TermDefinition
Surgical ultrasound imaging transducerA hand-held ultrasound imaging transducer assembly designed to be positioned within a surgical site for localized intraoperative imaging applications. It is sometimes referred to as a surgical probe or fingertip probe. It steers, focuses, and detects the ultrasound beam and resulting echoes either mechanically or electronically. This group of devices includes ultrasound imaging transducer assemblies used with A-mode, B-mode, M-mode, Doppler, colour Doppler (CD), and duplex (combination imaging, Doppler and/or colour flow) scanning capabilities. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method
Liquid Chemical;Peracetic Acid;Hydrogen Peroxide;Ethylene Oxide
Liquid Chemical;Peracetic Acid;Hydrogen Peroxide;Ethylene Oxide;High-level Disinfectant

Regulatory Flags#

DUNS number
718262719
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04573596204382FUJIFILMFCT iStream 2024-07-12
04573596212011L31KPL31KP2024-01-25
04573596212318S3ESCLSS3ESCLS2024-01-25
04573596212035L35L352024-01-22
04573596212455UST-2266-5UST-2266-52024-01-22
04573596214176CL4416R1CL4416R12024-01-22
04573596214336C421C4212024-01-22
04573596214503CC41R2CC41R22024-01-22
04573596214510C253AC253A2024-01-22
04573596214527ARIETTA x10ARIETTA x102024-01-22
04573596212691UST-5311-TIPUST-5311-TIP2022-09-09
04573596214381ARIETTA 650ARIETTA 6502022-02-07
04573596213247UST-9113P-3.5UST-9113P-3.52021-07-19
04573596210062ASU-1013ASU-10132021-07-18
04573596210079ASU-1014ASU-10142021-07-18
04573596210116BA-001BA-0012021-07-18
04573596210260MP-2448MP-24482021-07-17
04573596210345MP-2456MP-24562021-07-17
04573596210352MP-2458MP-24582021-07-17
04573596210376MP-2473MP-24732021-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00845225012939IntraSight PlusPhilips Image Guided Therapy CorporationIYO2026-05-26
00845225012946IntraSight PlusPhilips Image Guided Therapy CorporationIYO2026-05-26
06974405095104CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IYO2026-05-26
06974405095159CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IYO2026-05-26
06974405095166CarbonMedCarbon (Shenzhen) Medical Device Co., Ltd.IYO2026-05-26
D510DUS6000ADVANCED DIGITAL PORTABLE ULTRASONIC SYSTEM ADVANCED INSTRUMENTATIONS, INC.IYO2026-03-24
10841716103992ACIST HDi™ CartACIST MEDICAL SYSTEMS, INC.IYO2026-03-04
04987670102813DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.IYO2026-03-01
06975345060108Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.IYO2026-01-31
16978669290012Astrasono A5Pro Bladder ScannerAstrasono technology co.,ltd.IYO2026-01-15
20841436126346Tracking Bracket Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.IYO2025-12-31
00198953042816LOGIQGe Medical Systems, Ultrasound & Primary Care Diagnostics LlcIYO2025-12-05
00841517112141Sonosite MTFUJIFILM SONOSITE, INC.IYO2025-11-24
00841517112196Sonosite MTFUJIFILM SONOSITE, INC.IYO2025-11-24
16978669290005Astrasono A3Pro Bladder ScannerAstrasono technology co.,ltd.IYO2025-11-20
00198953001431Venue GoGe Medical Systems, Ultrasound & Primary Care Diagnostics LlcIYO2025-11-17
00198953079256VscanGE Vingmed Ultrasound ASIYO2025-11-17
00845225012984Patient Interface Module (PIMr)Philips Image Guided Therapy CorporationIYO2025-08-22
06971679948945Shear Wave Quantificational Ultrasound Diagnostic SystemWuxi Hisky Medical Technologies Co.,Ltd.IYO2025-08-05
00198953001073VenueGe Medical Systems, Ultrasound & Primary Care Diagnostics LlcIYO2025-07-31
00198953001097Venue GoGe Medical Systems, Ultrasound & Primary Care Diagnostics LlcIYO2025-07-31
06938396400484SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2025-07-21
06938396400965SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2025-07-21
06938396400972SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2025-07-21
06938396400989SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2025-07-21
06938396400996SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2025-07-21
06938396401016SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2025-07-21
06938396401023SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2025-07-21
06938396401030SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2025-07-21
06938396401047SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.IYO2025-07-21