REAL System Bands

GUDID 00815948022416

REAL System Bands

PENUMBRA, INC.

Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical Virtual-display rehabilitation system, non-supportive, clinical
Primary Device ID00815948022416
NIH Device Record Key697a1ab4-eec8-4d7f-a51f-ee7599ef8cd4
Commercial Distribution StatusIn Commercial Distribution
Brand NameREAL System Bands
Version Model NumberBND-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 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
GS100815948022416 [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.

00815948024779 - Swift Coil System2024-04-24 SwiftPAC Coil, 3 cm
00815948024793 - Swift Coil System2024-04-24 SwiftPAC Coil, 4 cm
00815948029460 - REAL y-Series2024-04-24 REAL y-Series 2
00815948029477 - REAL y-Series2024-04-24 REAL y-Series 2 Eval
00815948029484 - REAL y-Series2024-04-24 REAL y-Series GO
00815948029507 - Swift Coil System2024-04-24 SwiftPAC Coil, 5 cm
00815948029514 - Swift Coil System2024-04-24 SwiftPAC Coil, 6 cm
00815948029521 - Swift Coil System2024-04-24 SwiftPAC Coil, 7 cm
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