Phased probe

GUDID 06945121410274

CHISON Medical Technologies Co., Ltd.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID06945121410274
NIH Device Record Keyf6c105c7-5823-47ea-826c-5d8deb10e276
Commercial Distribution StatusIn Commercial Distribution
Brand NamePhased probe
Version Model NumberP2-ES
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
GS106945121409957 [Primary]
GS106945121410274 [Package]
Contains: 06945121409957
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 [Phased probe]

06945121412377D5P64L
06945121412360D3P64LS
06945121410274P2-ES
06945121410106P6-E
06945121410090P3-E
06945121410083P2-E

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