ICTx/8-5 MHz P07690

GUDID 00841517103750

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

Rectal/vaginal ultrasound imaging transducer
Primary Device ID00841517103750
NIH Device Record Key0ac63696-847f-4b3c-bbca-93762335474a
Commercial Distribution StatusIn Commercial Distribution
Brand NameICTx/8-5 MHz
Version Model NumberP07690-72A
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
Emailxyz@xyz.com

Operating and Storage Conditions

Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517103750 [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 Number3
Public Version Date2018-07-06
Device Publish Date2018-03-02

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00841517108939diagnostic Ultrasound transducer
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