REAL Immersive System

GUDID 00815948024243

REAL y-Series, Eval Use

PENUMBRA, INC.

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Primary Device ID00815948024243
NIH Device Record Keyb9746ead-851f-48c7-a3de-22822aaafa19
Commercial Distribution StatusIn Commercial Distribution
Brand NameREAL Immersive System
Version Model NumberRLY1V-A
Company DUNS191077671
Company NamePENUMBRA, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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
GS100815948024243 [Primary]

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 Date2022-03-29
Device Publish Date2022-03-21

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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