REAL Immersive System

GUDID 00815948024212

REAL Immersive System, Edu Use

PENUMBRA, INC.

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Primary Device ID00815948024212
NIH Device Record Keye5221c51-c8af-41ba-8e11-8d96c2c5163d
Commercial Distribution StatusIn Commercial Distribution
Brand NameREAL Immersive System
Version Model NumberREAL1S-A
Company DUNS191077671
Company NamePENUMBRA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
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
GS100815948024212 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ISDExerciser, Measuring

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-23
Device Publish Date2021-08-13

On-Brand Devices [REAL Immersive System]

00815948021037REAL Immersive System
00815948024212REAL Immersive System, Edu Use
00815948024205REAL Immersive System, Eval Use
00815948024229REAL i-Series
00815948024250REAL y-Series, Edu Use
00815948024243REAL y-Series, Eval Use
00815948024236REAL y-Series
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