FibroScan

GUDID 03662264000065

Pediatric probe

ECHOSENS

Hepatic ultrasound elastography system applicator
Primary Device ID03662264000065
NIH Device Record Keyf70fce9a-7cec-42f7-af33-62a6090b9561
Commercial Distribution StatusIn Commercial Distribution
Brand NameFibroScan
Version Model NumberS+
Company DUNS571069108
Company NameECHOSENS
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+33149818929
Emailservice@echosens.com

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS103662264000065 [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 Date2020-03-11
Device Publish Date2016-09-23

On-Brand Devices [FibroScan]

03662264001147FibroScan 430 MINI+
03662264001062FibroScan 530 Compact
03662264001048FibroScan 502 Touch
03662264001031FibroScan 502 Touch
03662264000072XL+
03662264000065Pediatric probe
03662264000058Adult probe
03662264001161FibroScan 630
03662264001222FibroScan 230

Trademark Results [FibroScan]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FIBROSCAN
FIBROSCAN
79094348 4072585 Live/Registered
ECHOSENS
2011-01-27
FIBROSCAN
FIBROSCAN
79016519 3209344 Live/Registered
ECHOSENS
2005-08-25
FIBROSCAN
FIBROSCAN
74721757 not registered Dead/Abandoned
Immunomedics, Inc.
1995-08-28
FIBROSCAN
FIBROSCAN
74214670 not registered Dead/Abandoned
IMMUNOMEDICS, INC.
1991-10-23

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