L38xi/10-5 MHz P12742

GUDID 00841517103156

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00841517103156
NIH Device Record Key1c125b8e-30d3-432f-b6ef-773a734d1a34
Commercial Distribution StatusIn Commercial Distribution
Brand NameL38xi/10-5 MHz
Version Model NumberP12742-10A
Catalog NumberP12742
Company DUNS014438860
Company NameFUJIFILM SONOSITE, 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

Customer Support Contacts

Phone+1(999)999-9999
Emailxyz@xyz.com

Operating and Storage Conditions

Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517103156 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Number5
Public Version Date2020-02-28
Device Publish Date2017-10-24

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00841517103477Diagnostic Ultrasound Transducer
00841517100476Diagnostic Ultrasound Transducer
00841517100469Diagnostic Ultrasound Transducer
00841517106898Diagnostic Ultrasound Transducer
00841517108991Diagnostic Ultrasound Transducer
00841517110505Diagnostic Ultrasound Transducer

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