DE10-3E Ultrasonic Probe(FDA)

GUDID 06944904088679

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Rectal/vaginal ultrasound imaging transducer
Primary Device ID06944904088679
NIH Device Record Key05e249a6-9c8b-48e7-9dad-ea482cce0440
Commercial Distribution StatusIn Commercial Distribution
Brand NameDE10-3E Ultrasonic Probe(FDA)
Version Model Number120-990021-00
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
GS106944904088679 [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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