MEDWS

GUDID 03665587000002

MED.E.COM

Diagnostic x-ray digital imaging system workstation application software
Primary Device ID03665587000002
NIH Device Record Key2a234bc8-3335-47ba-9387-bcfff9e99fe1
Commercial Distribution Discontinuation2019-06-12
Commercial Distribution StatusNot in Commercial Distribution
Brand NameMEDWS
Version Model Number4.15
Company DUNS393382168
Company NameMED.E.COM
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 Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+33298465248
Emailinfo@medecom.fr

Device Identifiers

Device Issuing AgencyDevice ID
GS103665587000002 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-01-14
Device Publish Date2019-03-26

On-Brand Devices [MEDWS]

036655870000024.15
036655870000264.17
036655870000334.18
036655870000575.0
036655870000645.2
036655870000715.4
036655870000885.6
036655870000956.1

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