UHF22 Transducer 51414

GUDID 00841517100704

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00841517100704
NIH Device Record Keyed7ebe03-9384-4eca-988c-183fcd9308ca
Commercial Distribution StatusIn Commercial Distribution
Brand NameUHF22 Transducer
Version Model Number51414-10A
Catalog Number51414
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

Phone1-877-657-8118
Emailffss-service@fujifilm.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517100704 [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 Date2016-09-21

On-Brand Devices [UHF22 Transducer]

00841517104672Diagnostic Ultrasound Transducer
00841517104511Diagnostic Ultrasound Transducer
00841517102319Diagnostic Ultrasound Transducer
00841517102302Diagnostic Ultrasound Transducer
00841517100704Diagnostic Ultrasound Transducer
00841517100698Diagnostic Ultrasound Transducer

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