L38E/10-5 MHZ P05482

GUDID 00841517104016

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00841517104016
NIH Device Record Key759db172-e950-4b3a-ac12-fe9d232cbfff
Commercial Distribution StatusIn Commercial Distribution
Brand NameL38E/10-5 MHZ
Version Model NumberP05482-30
Catalog NumberP05482
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
Emailxx@xx.xx

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517104016 [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 StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-05-08

On-Brand Devices [L38E/10-5 MHZ]

00841517104016P05482-30
00841517104009P05482-26
00841517103422TRANSDUCER, L38E/10-5 MHZ, ROHS, REMAN
00841517103279TRANSDUCER, L38E/10-5 MHZ, ROHS
00841517103262TRANSDUCER, L38E/10-5 MHZ, ROHS
00841517102838P05482-26A
00841517102555P05482-71 
00841517101664TRANSDUCER, L38E/10-5 MHZ, ROHS, REMAN
00841517101183P05482-30A

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