Phased array probe

GUDID 06945121411615

CHISON Medical Technologies Co., Ltd.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID06945121411615
NIH Device Record Key1f9b5c90-56df-422b-b36b-0b780bb226ef
Commercial Distribution StatusIn Commercial Distribution
Brand NamePhased array probe
Version Model NumberT5-V
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
GS106945121411349 [Primary]
GS106945121411615 [Package]
Contains: 06945121411349
Package: [1 Units]
In Commercial Distribution

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 Date2018-07-06
Device Publish Date2017-06-16

On-Brand Devices [Phased array probe]

06945121411707P5-V
06945121411691P3T-V
06945121411684P2-V
06945121411615T5-V
06945121408363P3
06945121407502P3-A
06945121400268D2P64L
06945121400251D6P64L
06945121400244D3P64L
06945121413657P3T-T
06945121414005P2M-T
069451214145553S

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