Edge Stand P15800

GUDID 00841517102777

FUJIFILM SONOSITE, INC.

General-purpose ultrasound imaging system
Primary Device ID00841517102777
NIH Device Record Key01ee2d68-1948-479f-a2c7-2feff1c0cbd9
Commercial Distribution StatusIn Commercial Distribution
Brand NameEdge Stand
Version Model NumberP15800-16
Catalog NumberP15800
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
Emailxyz@xyz.com

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517102777 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYNSystem, imaging, pulsed doppler, ultrasonic

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 Date2017-09-22

On-Brand Devices [Edge Stand]

00841517102791P15800-25
00841517102784P15800-21
00841517102777P15800-16
00841517102142Diagnostic Ultrasound System Accessory
00841517102074P15800-27
00841517100025Diagnostic Ultrasound System Accessory
00841517105785P15800-50
00841517106447Diagnostic Ultrasound System Accessory
00841517108137Ultrasound Accessory

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