Universal Viewer

GUDID 00195278379610

MD UV 8 MEDICAL DEVICE

GE HEALTHCARE

Medical image management system
Primary Device ID00195278379610
NIH Device Record Keyc7ecf98e-0faa-46ba-9b32-4ce11b42784b
Commercial Distribution StatusIn Commercial Distribution
Brand NameUniversal Viewer
Version Model Number8
Company DUNS054324257
Company NameGE HEALTHCARE
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 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
GS100195278379610 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-23
Device Publish Date2021-07-15

On-Brand Devices [Universal Viewer]

00195278379610MD UV 8 MEDICAL DEVICE
00195278644039MD UV 8.1 MEDICAL DEVICE

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