Nisus NPWT Wound Kit

GUDID 00851675007203

Negative Pressure Wound Therapy Dressing, Wound Kit,FM-1.25-5-8-A-16 Thick Foam

CORK MEDICAL, LLC

Negative-pressure wound therapy system dressing set
Primary Device ID00851675007203
NIH Device Record Key85dedd79-4ac9-4639-9482-6824bd58c159
Commercial Distribution StatusIn Commercial Distribution
Brand NameNisus NPWT Wound Kit
Version Model NumberFM-1.25-5-8-A-16
Company DUNS015964214
Company NameCORK MEDICAL, LLC
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 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
GS100851675007203 [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 Date2018-07-06
Device Publish Date2016-11-09

On-Brand Devices [Nisus NPWT Wound Kit]

00851675007227Negative Pressure Wound Therapy Dressing, Wound Kit, WDK-250 Wound Kit, Small with 1.2.3. Drape
00851675007210Negative Pressure Wound Therapy Dressing, Wound Kit, WDK300T Wound Kit, Thick Foam with 1.2.3. D
00851675007203Negative Pressure Wound Therapy Dressing, Wound Kit,FM-1.25-5-8-A-16 Thick Foam
00851675007029Negative Pressure Wound Therapy Dressing, Wound Kit, Large with 1.2.3 Drape
00851675007012Negative Pressure Wound Therapy Dressing, Wound Kit, Medium with 1.2.3 Drape

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