Merge Z3D

GUDID 00842000100065

Stand alone software application.

MERGE HEALTHCARE SOLUTIONS INC.

Radiology picture archiving and communication system workstation
Primary Device ID00842000100065
NIH Device Record Key115eed65-22f0-4f97-a625-32fb2f1c5b05
Commercial Distribution StatusIn Commercial Distribution
Brand NameMerge Z3D
Version Model Number2.0
Company DUNS065626069
Company NameMERGE HEALTHCARE SOLUTIONS INC.
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 Numberfalse
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
GS100842000100065 [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 Number4
Public Version Date2019-05-15
Device Publish Date2017-09-05

On-Brand Devices [Merge Z3D ]

00842000100669Stand alone software application.
00842000100065Stand alone software application.

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