FDA.reportPublic FDA data

L14-5sp Linear Array Transducer

Primary DI
00851315007051
Brand
L14-5sp Linear Array Transducer
Company
ZONARE MEDICAL SYSTEMS, INC.
Model
L14-5sp
Device description
L14-5sp Linear Array Diagnostic Ultrasound Transducer
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00851315007051PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851315007051008513150070518513150070510851315007051

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
096113340
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851315007037E9-4 Endocavity TransducerE9-42016-09-23
00851315007181E9-3 Endocavity TransducerE9-32016-09-23
00851315007006Ultrasound System, ZS3ZS32016-09-23
00851315007013Ultrasound System, Z.One PROZ.One PRO2016-09-23
00851315007020L10-5 Linear Array TransducerL10-52016-09-23
00851315007044L8-3 Linear Array TransducerL8-32016-09-23
00851315007068P4-1c Phased Array TransducerP4-1c2016-09-23
00851315007075C9-3 Curved Array TransducerC9-32016-09-23
00851315007082L14-5w Linear Array TransducerL14-5w2016-09-23
00851315007099C6-2 Curved Array TransducerC6-22016-09-23
00851315007105P8-3TEE Multiplane TransducerP8-3TEE2016-09-23
00851315007112A2CW Continuous Wave TransducerA2CW2016-09-23
00851315007129C8-3 3D Curved Array TransducerC8-3 3D2016-09-23
00851315007136C4-1 Curved Array TransducerC4-12016-09-23
00851315007143E9-3 3D Curved Array TransducerE9-3 3D2016-09-23
00851315007150C10-3 Curved Array TransducerC10-32016-09-23
00851315007167L20-5 Linear Array TransducerL20-52016-09-23
00851315007174C9-3sp Curved Array TransducerC9-3sp2016-09-23
00851315007198A5CW Continuous Wave TransducerA5CW2016-09-23
00851315007204Z-PAK Battery PackZ-PAK2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06948941160022Bladder ScannerMeda Co., LtdITX2026-10-08
04719873009510"Esaote MyLabX1" Ultrasound Transducer_Linear ArrayQISDA CORPORATIONITX2026-10-01
04719873009534"Esaote MyLabX1" Ultrasound Transducer_Phased ArrayQISDA CORPORATIONITX2026-10-01
06975424191037Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.ITX2026-10-01
08809887550170EdgeFlow UH10CEdgeCare Inc.ITX2026-09-30
08809887550187EdgeFlow UH10EEdgeCare Inc.ITX2026-09-30
00860007188367FUJIFILMFujifilm Healthcare Americas CorporationITX2026-09-29
00195278985613NAGE Medical Systems (China) Co.,Ltd.ITX2026-09-24
00198953126073VividGE Vingmed Ultrasound A/SITX2026-09-21
00198953172384VividGE Vingmed Ultrasound A/SITX2026-09-21
00198953172551VividGE Vingmed Ultrasound A/SITX2026-09-21
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCITX2026-09-18
03701104600420T-LiteSONOSCANNERITX2026-08-25
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