ICTx/8-5 MHz

GUDID 00841517100797

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

Rectal/vaginal ultrasound imaging transducer
Primary Device ID00841517100797
NIH Device Record Keyf84aac0c-13b3-4403-9374-a198f389db15
Commercial Distribution StatusIn Commercial Distribution
Brand NameICTx/8-5 MHz
Version Model NumberP11881-71
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

Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517100797 [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 Date2016-09-14

On-Brand Devices [ICTx/8-5 MHz]

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.