35C50EB Ultrasonic Transducer(FDA)

GUDID 06944904087382

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Extracorporeal ultrasound imaging transducer, hand-held
Primary Device ID06944904087382
NIH Device Record Keycf2ead69-c0ad-4467-8452-3e5c69cb7e9a
Commercial Distribution StatusIn Commercial Distribution
Brand Name35C50EB Ultrasonic Transducer(FDA)
Version Model Number120-000770-00
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
GS106944904087382 [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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