ICTxp/9-5 MHz

GUDID 00841517101077

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

Rectal/vaginal ultrasound imaging transducer
Primary Device ID00841517101077
NIH Device Record Keybeb8d549-882e-44af-aba1-34ce2e9e836b
Commercial Distribution StatusIn Commercial Distribution
Brand NameICTxp/9-5 MHz
Version Model NumberP14562-21A
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 Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517101077 [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 [ICTxp/9-5 MHz]

00841517101077Diagnostic Ultrasound Transducer
00841517101060Diagnostic Ultrasound Transducer
00841517106249Diagnostic Ultrasound Transducer
00841517106225Diagnostic Ultrasound Transducer
00841517106102Diagnostic Ultrasound Transducer
00841517107123Diagnostic Ultrasound Transducer
00841517109479Diagnostic Ultrasound Transducer

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