ICTx/8-5 MHz

GUDID 00841517100421

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

Rectal/vaginal ultrasound imaging transducer
Primary Device ID00841517100421
NIH Device Record Keyb711f643-ea07-4c33-8516-4b959a353d9d
Commercial Distribution StatusIn Commercial Distribution
Brand NameICTx/8-5 MHz
Version Model NumberP07690-71A
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
GS100841517100421 [Primary]

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 Number3
Public Version Date2018-05-23
Device Publish Date2016-09-13

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00841517105051Diagnostic Ultrasound Transducer
00841517104849Diagnostic Ultrasound Transducer
00841517103750Diagnostic Ultrasound Transducer
00841517103743Diagnostic Ultrasound Transducer
00841517102890Diagnostic Ultrasound Transducer
00841517100803Diagnostic Ultrasound Transducer
00841517100797Diagnostic Ultrasound Transducer
00841517100421Diagnostic Ultrasound Transducer
00841517100414Diagnostic Ultrasound Transducer
00841517106287Diagnostic Ultrasound Transducer
00841517106232Diagnostic Ultrasound Transducer
00841517106935Diagnostic Ultrasound Transducer
00841517107390Diagnostic Ultrasound Transducer
00841517108939diagnostic Ultrasound transducer
00841517110512Diagnostic Ultrasound Transducer

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