5D Viewer

GUDID 08806167789466

SAMSUNG MEDISON CO., LTD.

Radiology PACS software
Primary Device ID08806167789466
NIH Device Record Keyef2f0c8d-7a90-4fb8-8363-4331a009895e
Commercial Distribution StatusIn Commercial Distribution
Brand Name5D Viewer
Version Model NumberUSO-U0N5B0K/WR
Company DUNS687785691
Company NameSAMSUNG MEDISON 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 Datefalse
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
GS108806167789466 [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 Number6
Public Version Date2020-01-10
Device Publish Date2018-05-26

On-Brand Devices [5D Viewer]

08806167789466USO-U0N5B0K/WR
08806167761172USO-U0N5B0B/WR

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