L14-5sp Linear Array Transducer

GUDID 00851315007051

L14-5sp Linear Array Diagnostic Ultrasound Transducer

ZONARE MEDICAL SYSTEMS, INC.

Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer Surgical ultrasound imaging transducer
Primary Device ID00851315007051
NIH Device Record Key09777628-97ea-4d89-b80b-e5ef4d2da092
Commercial Distribution StatusIn Commercial Distribution
Brand NameL14-5sp Linear Array Transducer
Version Model NumberL14-5sp
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
GS100851315007051 [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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00851315007051 - L14-5sp Linear Array Transducer2018-05-23L14-5sp Linear Array Diagnostic Ultrasound Transducer
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