SonoSite Edge P15000

GUDID 00841517103187

FUJIFILM SONOSITE, INC.

General-purpose ultrasound imaging system
Primary Device ID00841517103187
NIH Device Record Keyf43472c8-58de-4739-8ef5-28b619b9b5c4
Commercial Distribution StatusIn Commercial Distribution
Brand NameSonoSite Edge
Version Model NumberP15000-14R
Catalog NumberP15000
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

Handling Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100841517103187 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYOSystem, imaging, pulsed echo, 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 Date2017-10-24

On-Brand Devices [SonoSite Edge]

00841517103897P15000-67R
00841517103217P15000-63R
00841517103200P15000-18R
00841517103194P15000-15R
00841517103187P15000-14R
00841517103170P15000-13R
00841517103163P15000-12R
00841517102678P15000-63
00841517102661P15000-60
00841517102654P15000-18
00841517102647P15000-15
00841517102517P15000-21R
00841517102500P15000-21
00841517102098P15000-67
00841517101770P15000-66R
00841517101763P15000-20R
00841517101725P15000-66
00841517101718P15000-20
00841517101381P15000-19R
00841517101374P15000-19
00841517100247P15000-64R
00841517100230P15000-64
00841517105754P28961-68R
00841517105723P28961-68
00841517105457P15000-22
00841517105440P15000-22R
00841517105433P15000-68
00841517105426P15000-68R
00841517107925SONOSITE EDGE II ULTRASOUND SYSTEM, INDIA

Trademark Results [SonoSite Edge]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SONOSITE EDGE
SONOSITE EDGE
85378897 not registered Dead/Abandoned
SonoSite, Inc.
2011-07-22

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