TEExp/8-3 MHz

GUDID 00841517101152

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

Oesophageal ultrasound imaging transducer, reusable
Primary Device ID00841517101152
NIH Device Record Key94c2fbdf-18e4-4747-9540-5e2d84af5d6d
Commercial Distribution StatusIn Commercial Distribution
Brand NameTEExp/8-3 MHz
Version Model NumberP19620-20
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
GS100841517101152 [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 Date2016-09-15

On-Brand Devices [TEExp/8-3 MHz]

00841517101152Diagnostic Ultrasound Transducer
00841517107116Diagnostic Ultrasound Transducer

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