ICTx/8-5 MHz P07690

GUDID 00841517105051

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

Rectal/vaginal ultrasound imaging transducer
Primary Device ID00841517105051
NIH Device Record Keyc33fc2ca-8cb7-4b2b-8f9f-8dc2d555e9f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameICTx/8-5 MHz
Version Model NumberP07690-80A
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

Handling Environment TemperatureBetween -35 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517105051 [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 Date2019-09-02
Device Publish Date2019-08-23

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00841517100421Diagnostic Ultrasound Transducer
00841517100414Diagnostic Ultrasound Transducer
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00841517108939diagnostic Ultrasound transducer
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