ICTx/8-5 MHz P07690

GUDID 00841517104849

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

Rectal/vaginal ultrasound imaging transducer
Primary Device ID00841517104849
NIH Device Record Keyad2f4597-9ae0-4b55-b7f5-ae479c055b71
Commercial Distribution StatusIn Commercial Distribution
Brand NameICTx/8-5 MHz
Version Model NumberP07690-80
Catalog NumberP07690
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 Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517104849 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-08-01
Device Publish Date2019-07-24

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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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