Pencil probe

GUDID 06945121411592

CHISON Medical Technologies Co., Ltd.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID06945121411592
NIH Device Record Keyf61e9bd3-f3c8-45a9-8815-51557a315ff8
Commercial Distribution StatusIn Commercial Distribution
Brand NamePencil probe
Version Model NumberCW2-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
GS106945121411325 [Primary]
GS106945121411592 [Package]
Contains: 06945121411325
Package: [1 Units]
In Commercial Distribution
GS106945121413565 [Package]
Contains: 06945121411325
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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2017-06-16

On-Brand Devices [Pencil probe]

06945121411592CW2-V
06945121410328CW2-E
06945121400275D2D16L

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.