Diagnostic Ultrasound System

GUDID 06944413811454

Edan Instruments, Inc.

General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system
Primary Device ID06944413811454
NIH Device Record Key08eec425-348d-45da-8e41-9695e07e4f0e
Commercial Distribution StatusIn Commercial Distribution
Brand NameDiagnostic Ultrasound System
Version Model NumberAcclarix AX3
Company DUNS529173163
Company NameEdan Instruments, 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

Device Identifiers

Device Issuing AgencyDevice ID
GS106944413811454 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-17
Device Publish Date2019-12-09

On-Brand Devices [Diagnostic Ultrasound System]

06944413810723U60
06944413808867Acclarix AX4
06944413807037P10
06944413807020DUS-5000
06944413802575Acclarix LX8
06944413802544Acclarix LX7
06944413802315Acclarix AX7
06944413802285Acclarix AX8
06944413801721U2
06944413801714U50
06944413811584Acclarix AX18
06944413811560Acclarix AX15
06944413811546Acclarix AX28
06944413811522Acclarix AX25
06944413811508Acclarix AX2 Exp
06944413811492Acclarix AX2 Super
06944413811485Acclarix AX2
06944413811478Acclarix AX3 Exp
06944413811461Acclarix AX3 Super
06944413811454Acclarix AX3
06944413813342Acclarix LX28
06944413813328Acclarix LX25
06944413813311Acclarix LX3 Exp
06944413813304Acclarix LX3 Super
06944413813298Acclarix LX3

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.