Digital Ultrasound Scanner

GUDID 06972174670034

Shenzhen Well.D Medical Electronics Co.,Ltd.

General-purpose ultrasound imaging system
Primary Device ID06972174670034
NIH Device Record Key9f05819a-e759-442d-85bf-2201e744f74f
Commercial Distribution StatusIn Commercial Distribution
Brand NameDigital Ultrasound Scanner
Version Model NumberWED-3100
Company DUNS421472085
Company NameShenzhen Well.D Medical Electronics 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
GS106972174670034 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-01
Device Publish Date2019-01-29

Devices Manufactured by Shenzhen Well.D Medical Electronics Co.,Ltd.

06972174670034 - Digital Ultrasound Scanner2019-03-01
06972174670034 - Digital Ultrasound Scanner2019-03-01
06972174670010 - Color Doppler Ultrasound System2019-02-28
06972174670027 - Color Doppler Ultrasound System2019-02-28

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