REAL Sensor Bands

GUDID 00815948021389

REAL Sensor Bands for the REAL Immersive System

PENUMBRA, INC.

Virtual-display rehabilitation system, non-supportive, clinical
Primary Device ID00815948021389
NIH Device Record Key2205cbe9-558e-4a7d-918c-cef0ec4c9e43
Commercial Distribution StatusIn Commercial Distribution
Brand NameREAL Sensor Bands
Version Model NumberBND
Company DUNS191077671
Company NamePENUMBRA, INC.
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 Usetrue
Lot Batchtrue
Serial Numberfalse
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
GS100815948021389 [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-06-08
Device Publish Date2020-06-17

Devices Manufactured by PENUMBRA, INC.

00810169720004 - Indigo System2024-10-16 CAT12 100 XTORQ plus Lightning Bolt Aspiration Tubing, no CE
00810169720011 - Indigo System2024-10-16 CAT12 100 HTORQ plus Lightning Bolt Aspiration Tubing, no CE
00810169720028 - Indigo System2024-10-16 CAT12 115 XTORQ plus Lightning Bolt Aspiration Tubing, no CE
00810169720035 - Indigo System2024-10-16 CAT12 115 HTORQ plus Lightning Bolt Aspiration Tubing, no CE
00810169721179 - Indigo System2024-10-16 CAT6X + Lightning Bolt
00810169721186 - Indigo System2024-10-16 CAT6X w/Sonic + Lightning Bolt
M242RBYPODJ150 - POD2024-08-23 RBYPODJ15 GS1-00814548016702
00815948024267 - Indigo System2024-07-26 CAT16 HTORQ 115cm, Select + 135cm BER Tip, Lightning Flash 2.0 Tubing

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