Pencil probe

GUDID 06945121400275

CHISON Medical Technologies Co., Ltd.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID06945121400275
NIH Device Record Keyb015960b-bc79-42f8-8d55-3afb803c5646
Commercial Distribution StatusIn Commercial Distribution
Brand NamePencil probe
Version Model NumberD2D16L
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
GS106945121400275 [Primary]

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 Date2016-09-28

On-Brand Devices [Pencil probe]

06945121411592CW2-V
06945121410328CW2-E
06945121400275D2D16L

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