UHF48 Transducer 51415

GUDID 00841517102333

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00841517102333
NIH Device Record Keyf011355c-9c59-4fb9-86b3-8221b9fe78f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameUHF48 Transducer
Version Model Number51415-30A
Catalog Number51415
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
GS100841517102333 [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 Number4
Public Version Date2018-07-06
Device Publish Date2017-07-21

On-Brand Devices [UHF48 Transducer]

00841517104689Diagnostic Ultrasound Transducer
00841517104528Diagnostic Ultrasound Transducer
00841517102333Diagnostic Ultrasound Transducer
00841517102326Diagnostic Ultrasound Transducer
00841517100728Diagnostic Ultrasound Transducer
00841517100711Diagnostic Ultrasound Transducer

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