C11x/8-5 MHz

GUDID 00841517100056

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

General-purpose ultrasound imaging system
Primary Device ID00841517100056
NIH Device Record Key3e4eb3cf-1f9e-4112-9ca9-9d112b44cfd5
Commercial Distribution StatusIn Commercial Distribution
Brand NameC11x/8-5 MHz
Version Model NumberP07678-70
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
GS100841517100056 [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 Date2016-09-13

On-Brand Devices [C11x/8-5 MHz]

00841517105020Diagnostic Ultrasound Transducer
00841517104962Diagnostic Ultrasound Transducer
00841517102869Diagnostic Ultrasound Transducer
00841517102852Diagnostic Ultrasound Transducer
00841517100292Diagnostic Ultrasound Transducer
00841517100056Diagnostic Ultrasound Transducer
00841517106966Diagnostic Ultrasound Transducer
00841517107345Diagnostic Ultrasound Transducer
00841517108588Diagnostic Ultrasound Transducer
00841517108908Diagnostic ultrasound transducer
00841517110468Diagnostic Ultrasound Transducer

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