line array probe

GUDID 06945121414135

CHISON Medical Technologies Co., Ltd.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID06945121414135
NIH Device Record Key6e8c3322-3d9d-4a80-a5c6-a67927658a7e
Commercial Distribution StatusIn Commercial Distribution
Brand Nameline array probe
Version Model NumberL18-T
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
GS106945121414135 [Primary]
GS106945121414425 [Package]
Package: [2 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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-09
Device Publish Date2022-09-01

On-Brand Devices [line array probe]

06945121413527L12M-T
06945121414135L18-T
06945121414272L10i-T
06945121414265L7R-T

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