Edge Mini-Dock

GUDID 00841517100117

FUJIFILM SONOSITE, INC.

General-purpose ultrasound imaging system
Primary Device ID00841517100117
NIH Device Record Key122a869f-11dd-4264-b892-a52f30ca7b8a
Commercial Distribution StatusIn Commercial Distribution
Brand NameEdge Mini-Dock
Version Model NumberP15078-41
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 TemperatureBetween -35 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517100117 [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 Date2016-09-12

On-Brand Devices [Edge Mini-Dock]

00841517100117P15078-41
00841517107598P15078-16
00841517108113MINIDOCK, DESKTOP VERSION
00841517108373Edge Accessory
00841517110369DIAGNOSTIC ULTRASOUND ACCAESSORY

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