FDA.reportPublic FDA data

Ultrasonix Medical Corporation

Primary DI
08294360350697
Brand
Ultrasonix Medical Corporation
Company
ANALOGIC CORPORATION
Model
00.035.069
Device description
4DL14-5/38 Linear transducer
Published
2017-11-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08294360350697PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08294360350697082943603506978294360350697

GMDN Terms#

Term, Definition table
TermDefinition
Extracorporeal ultrasound imaging transducer, hand-heldA hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient's body, typically with a coupling gel, during a variety of extracorporeal ultrasound imaging procedures (non-dedicated). Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to an ultrasound system controller for image processing and display. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-604-279-8550techsupport@bkultrasound.com

Regulatory Flags#

DUNS number
019677418
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
90814277020035Pathfinder Shadow BK-T10-77322S-012016-09-17
90814277020042Pathfinder Shadow 10-77247S-012016-09-17
90814277020059Pathfinder Shadow (Aloka)10-77246S-012016-09-17
90814277020066Pathfinder Small Multi-Tool Instrument Clamp10-77260S-012016-09-17
90814277020073Pathfinder Large Multi-Tool Instrument Clamp10-77249S-012016-09-17
90814277020080Pathfinder Beacon10-77248S-012016-09-17
90814277020097Pathfinder Tracer10-77243S-012016-09-17
90814277020103Pathfinder Long Probe10-77242S-012016-09-17
90814277020110Pathfinder Tracked Probe10-77241S-012016-09-17
08294360350536Ultrasonix Medical Corporation00.035.0532017-11-17
08294360246341Ultrasonix Medical Corporation00.024.6342017-11-17
08294360350352Ultrasonix Medical Corporation00.035.0352017-11-17
08294360350499Ultrasonix Medical Corporation00.035.0492017-11-17
08294360350567Ultrasonix Medical Corporation00.035.0562017-11-17
08294360350581Ultrasonix Medical Corporation00.035.0582017-11-17
08294360350604Ultrasonix Medical Corporation00.035.0602017-11-17
08294360350611Ultrasonix Medical Corporation00.035.0612017-11-17
08294360350635Ultrasonix Medical Corporation00.035.0632017-11-17
08294360350642Ultrasonix Medical Corporation00.035.0642017-11-17
08294360350666Ultrasonix Medical Corporation00.035.0662017-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08800290029376CA2-13MSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800290036169PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800290036237BCC2-13SAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
00841517112684C5-1FUJIFILM SONOSITE, INC.ITX2026-08-07
00841436122078Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436122900Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436124294Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436125895Needle Guide Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126052Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126403Needle Guide Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126410Needle Guide BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27