L25n/13-6 MHz

GUDID 00841517100810

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID00841517100810
NIH Device Record Key42f8c50c-a3c9-4933-b3d1-8d020f889203
Commercial Distribution StatusIn Commercial Distribution
Brand NameL25n/13-6 MHz
Version Model NumberP12092-70
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

Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517100810 [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 Date2016-09-14

On-Brand Devices [L25n/13-6 MHz]

00841517104627Diagnostic Ultrasound Transducer
00841517104306Diagnostic Ultrasound Transducer
00841517104290Diagnostic Ultrasound Transducer
00841517104177Diagnostic Ultrasound Transducer
00841517104085Diagnostic Ultrasound Transducer
00841517103149Diagnostic Ultrasound Transducer
00841517100827Diagnostic Ultrasound Transducer
00841517100810Diagnostic Ultrasound Transducer

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