SLAx/13-6 MHz

GUDID 00841517100629

Diagnostic Ultrasound Transducer

FUJIFILM SONOSITE, INC.

Surgical ultrasound imaging transducer
Primary Device ID00841517100629
NIH Device Record Key81057b35-66f8-4743-af6e-a86d00e6677b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSLAx/13-6 MHz
Version Model NumberP07699-70A
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 HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517100629 [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 Date2016-09-13

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

00841517104955Diagnostic Ultrasound Transducer
00841517104092Diagnostic Ultrasound Transducer
00841517103453Diagnostic Ultrasound Transducer
00841517103293Diagnostic Ultrasound Transducer
00841517102951Diagnostic Ultrasound Transducer
00841517102944Diagnostic Ultrasound Transducer
00841517100629Diagnostic Ultrasound Transducer
00841517100612Diagnostic Ultrasound Transducer
00841517105099P07699-72
00841517106928Diagnostic Ultrasound Transducer
00841517107680P07699-80A
00841517107949Diagnostic ultrasound transducer

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