C60xf/5-2 MHz

GUDID 00841517101169

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00841517101169
NIH Device Record Key9e6398f0-02bd-4c25-b60c-a7c247cab12a
Commercial Distribution StatusIn Commercial Distribution
Brand NameC60xf/5-2 MHz
Version Model NumberP18024-20
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 TemperatureBetween -35 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517101169 [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 [C60xf/5-2 MHz]

00841517103514TRANSDUCER, C60XF/5-2 MHZ, ROHS, REMAN
00841517103507TRANSDUCER, C60XF/5-2 MHZ, ROHS
00841517101176P18024-20A
00841517101169P18024-20
00841517107208Diagnostic Ultrasound Transducer
00841517109547Diagnostic ultrasound transducer

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