C60x/5-2 MHz P07680

GUDID 00841517100308

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00841517100308
NIH Device Record Key0bb0da5e-483e-4fc7-8a36-2b9ccf1c92a1
Commercial Distribution StatusIn Commercial Distribution
Brand NameC60x/5-2 MHz
Version Model NumberP07680-70
Catalog NumberP07680
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

Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517100308 [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 Date2017-11-20

On-Brand Devices [C60x/5-2 MHz]

00841517104979Diagnostic Ultrasound Transducer
00841517104429Diagnostic Ultrasound Transducer
00841517103705Diagnostic Ultrasound Transducer
00841517103446Diagnostic Ultrasound Transducer
00841517103354Diagnostic Ultrasound Transducer
00841517102876Diagnostic Ultrasound Transducer
00841517100315Diagnostic Ultrasound Transducer
00841517100308Diagnostic Ultrasound Transducer
00841517107000Diagnostic Ultrasound Transducer
00841517108557Diagnostic Ultrasound Transducer

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