OptiVu Streamer

GUDID 07649988969867

INCREMED AG

Video image processor
Primary Device ID07649988969867
NIH Device Record Key356681cb-8a52-49a5-a4ed-2422f4215690
Commercial Distribution StatusIn Commercial Distribution
Brand NameOptiVu Streamer
Version Model NumberR2.X.Y
Company DUNS480257180
Company NameINCREMED AG
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
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
GS107649988969867 [Primary]

FDA Product Code

LMDSystem, Digital Image Communications, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-02
Device Publish Date2025-04-24

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