35C20EA Ultrasonic Transducer(FDA)

GUDID 06944904089416

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID06944904089416
NIH Device Record Key9872127a-1115-44a9-91a9-289b00312a7c
Commercial Distribution StatusIn Commercial Distribution
Brand Name35C20EA Ultrasonic Transducer(FDA)
Version Model NumberPR2C-30-90948
Company DUNS654671304
Company NameShenzhen Mindray Bio-Medical Electronics Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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

Customer Support Contacts

Phone+8675581888998
Emailservice@mindray.com.cn

Device Identifiers

Device Issuing AgencyDevice ID
GS106944904089416 [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 Date2016-09-23

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