PREVENA RESTOR™ ARTHRO•FORM™

GUDID 00849554006812

PREVENA RESTOR™ ARTHRO•FORM™ DRESSING – 33CM X 30CM

KCI USA, INC.

Negative-pressure wound therapy system, battery-powered, single-use
Primary Device ID00849554006812
NIH Device Record Key9a2abbf6-f3f1-487d-9ab4-a1237f701805
Commercial Distribution StatusIn Commercial Distribution
Brand NamePREVENA RESTOR™ ARTHRO•FORM™
Version Model NumberPREVENA RESTOR™ ARTHRO•FORM™
Company DUNS102726734
Company NameKCI USA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100849554000681 [Package]
Contains: 00849554006959
Package: 1-PACK [1 Units]
In Commercial Distribution
GS100849554006812 [Package]
Contains: 00849554006959
Package: 5 PACK [5 Units]
In Commercial Distribution
GS100849554006959 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OMPNegative Pressure Wound Therapy Powered Suction Pump

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-10-14
Device Publish Date2019-03-04

On-Brand Devices [PREVENA RESTOR™ ARTHRO•FORM™]

00849554007116PREVENA RESTOR™ ARTHRO•FORM™ 46CM X 30CM SYSTEM KIT
00849554006812PREVENA RESTOR™ ARTHRO•FORM™ DRESSING – 33CM X 30CM
00849554007109PREVENA RESTOR™ ARTHRO•FORM™ DRESSING – 46CM X 30CM
00849554006805PREVENA RESTOR™ ARTHRO•FORM™ 33CM X 30CM SYSTEM KIT

Trademark Results [PREVENA RESTOR]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PREVENA RESTOR
PREVENA RESTOR
88099676 not registered Live/Pending
KCI LICENSING, INC.
2018-08-30

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