L10-5 Linear Array Transducer

GUDID 00851315007020

L10-5 Linear Array Diagnostic Ultrasonic Transducer

ZONARE MEDICAL SYSTEMS, INC.

Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00851315007020
NIH Device Record Keyba51a4fc-fdfa-4a96-a608-5ea7a4446abe
Commercial Distribution StatusIn Commercial Distribution
Brand NameL10-5 Linear Array Transducer
Version Model NumberL10-5
Company DUNS096113340
Company NameZONARE MEDICAL SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100851315007020 [Primary]

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-05-23
Device Publish Date2016-09-23

Devices Manufactured by ZONARE MEDICAL SYSTEMS, INC.

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00851315007020 - L10-5 Linear Array Transducer2018-05-23 L10-5 Linear Array Diagnostic Ultrasonic Transducer
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00851315007051 - L14-5sp Linear Array Transducer2018-05-23 L14-5sp Linear Array Diagnostic Ultrasound Transducer
00851315007068 - P4-1c Phased Array Transducer2018-05-23 P4-1c Phased Array Diagnostic Ultrasound Transducer
00851315007075 - C9-3 Curved Array Transducer2018-05-23 C9-3 Curved Array Diagnostic Ultrasonic Transducer

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