Tee probe

GUDID 06945121410311

CHISON Medical Technologies Co., Ltd.

Oesophageal ultrasound imaging transducer, reusable
Primary Device ID06945121410311
NIH Device Record Key1418eb74-1c9e-459d-937b-a4aa8974f593
Commercial Distribution StatusIn Commercial Distribution
Brand NameTee probe
Version Model NumberMT5-E
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
GS106945121409995 [Primary]
GS106945121410311 [Package]
Contains: 06945121409995
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 Date2016-09-24

On-Brand Devices [Tee probe]

06945121410311MT5-E
06945121410304T5-E
06945121403306T5P64L
06945121400299MT5P48L
06945121400282T5P64L

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