EBit Series Diagnostic Ultrasound System

GUDID 06945121409704

CHISON Medical Technologies Co., Ltd.

Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held Extracorporeal ultrasound imaging transducer, hand-held General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system
Primary Device ID06945121409704
NIH Device Record Key7c6d0db0-1100-4bd3-8abf-60de7eca6a91
Commercial Distribution StatusIn Commercial Distribution
Brand NameEBit Series Diagnostic Ultrasound System
Version Model NumberEBit 60
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
GS106945121409704 [Primary]
GS106945121410359 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410366 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410373 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410380 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410397 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410403 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410410 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410427 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410434 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410441 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410458 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410465 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410472 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410489 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410496 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410502 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410519 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410526 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410533 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410540 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410557 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410564 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410571 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410588 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410595 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410601 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410618 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410625 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410632 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410649 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410656 [Package]
Package: [1 Units]
In Commercial Distribution
GS106945121410663 [Package]
Package: [1 Units]
In Commercial Distribution

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 Date2016-09-24

On-Brand Devices [EBit Series Diagnostic Ultrasound System]

06945121410861EBit 50
06945121409704EBit 60
06945121412889EBit 30
06945121414494EBit 20
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