SonoBook Series Diagnostic Ultrasound Systems

GUDID 06945121413305

CHISON Medical Technologies Co., Ltd.

General-purpose ultrasound imaging system
Primary Device ID06945121413305
NIH Device Record Keye2524c44-7cc1-437c-931e-e4c05815395e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSonoBook Series Diagnostic Ultrasound Systems
Version Model NumberSonoBook 7
Company DUNS544914187
Company NameCHISON Medical Technologies Co., Ltd.
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
GS106945121413305 [Primary]
GS106945121413589 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121414241 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121414258 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121415163 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121415170 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121415446 [Package]
Package: [1 Units]
In Commercial Distribution

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 Date2021-10-05
Device Publish Date2021-09-27

On-Brand Devices [SonoBook Series Diagnostic Ultrasound Systems]

06945121412681SonoBook 8
06945121411172SonoBook 9
06945121413305SonoBook 7
06945121414166SonoBook 5

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