FDA.reportPublic FDA data

Nexa Foam

Primary DI
25060826400063
Brand
Nexa Foam
Company
NEXA MEDICAL LIMITED
Model
414-00-701
Device description
Single piece of foam used in Nexa Dressing.
Published
2023-08-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OMPNegative Pressure Wound Therapy Powered Suction Pump

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMPNegative Pressure Wound Therapy Powered Suction PumpGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162610000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162610000NEXA Negative Pressure Wound Therapy SystemNexa Medical , Ltd.2017-06-08OMP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060826400066PackageGS15In Commercial Distribution
25060826400063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1506082640006615060826400066
2506082640006325060826400063

GMDN Terms#

Term, Definition table
TermDefinition
Negative-pressure wound therapy system foam dressing, non-antimicrobialA pad made of open-cell foam material designed to be placed into a wound during a vacuum-assisted wound closure procedure, commonly known as negative pressure wound therapy (NPWT); it does not include an antimicrobial agent(s). It is typically used to treat hard-to-heal open wounds (e.g., acute, traumatic, and chronic), burns, diabetic/pressure ulcers, flaps and grafts. Under NPWT, the open-cell foam dressing decompresses capillaries/lymphatic vessels, improves blood/interstitial fluid circulation, draws wound edges together, facilitates granulation tissue formation, and prepares the wound bed for closure. It may be cut to conform to the wound. This is a single-use device.

Regulatory Flags#

DUNS number
221046947
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
25060826400056NEXA Drape414-00-6012023-08-30
35060826400015NEXA NPWT DRESSING -125mmHg414-00-1012023-08-30
35060826400039NEXA NPWT FLUID CONTAINER PACK414-00-1022023-08-30
15060826400004NEXA NPWT Device Kit414-00-3002023-08-30
15060826400059NEXA Drape414-00-6012023-08-30
15060826400066Nexa Foam414-00-7012023-08-30
15060826400011NEXA NPWT DRESSING -125mmHg414-00-1012023-08-30
15060826400035NEXA NPWT FLUID CONTAINER PACK414-00-1022023-08-30

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